<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717638</url>
  </required_header>
  <id_info>
    <org_study_id>V72P12E2</org_study_id>
    <secondary_id>2011-004931-30</secondary_id>
    <nct_id>NCT01717638</nct_id>
  </id_info>
  <brief_title>Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1</brief_title>
  <official_title>A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Vaccines</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second&#xD;
      extension study is to explore the bactericidal antibody persistence in 4-year-old children&#xD;
      after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV&#xD;
      NZ administered to toddlers as part of their respective vaccination courses in study&#xD;
      V72P12E1.&#xD;
&#xD;
      In addition, this study will characterize the antibody response to a fifth dose boost in all&#xD;
      children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age&#xD;
      (in parent study V72P12, NCT00721396), and only in a subset of children who received a&#xD;
      three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12).&#xD;
      Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ&#xD;
      administered at approximately 4 years of age in all children who received a two catch-up&#xD;
      doses of rMenB+OMV NZ as toddlers in study V72P12E1.&#xD;
&#xD;
      Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2&#xD;
      months apart to healthy naïve children at 4 years of age will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules</measure>
    <time_frame>Day 1 (24-36 months post booster; baseline for naive)</time_frame>
    <description>The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.&#xD;
The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules</measure>
    <time_frame>Day 1 (24-36 months post booster; baseline for naive)</time_frame>
    <description>The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules</measure>
    <time_frame>Day 1 (24-36 months post booster dose; baseline for naive)</time_frame>
    <description>The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules</measure>
    <time_frame>Day 1 (22-34 months post last MenB vaccine)</time_frame>
    <description>The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules</measure>
    <time_frame>Day 1 (22-36 months post last MenB vaccine; baseline for naive)</time_frame>
    <description>The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules</measure>
    <time_frame>Day 1 (22-34 months post last MenB vaccine)</time_frame>
    <description>The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</measure>
    <time_frame>Day 31 (1 month post vaccination)</time_frame>
    <description>The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</measure>
    <time_frame>Day 31 (1 month post vaccination)</time_frame>
    <description>The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</measure>
    <time_frame>Day 31 (1 month post vaccination)</time_frame>
    <description>The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</measure>
    <time_frame>Day 31 (1 month post vaccination)</time_frame>
    <description>The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules</measure>
    <time_frame>Day 31 (1 month post vaccination)</time_frame>
    <description>The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules</measure>
    <time_frame>Day 31 (1 month post vaccination)</time_frame>
    <description>The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.</measure>
    <time_frame>Day 31 (1 month post vaccination)</time_frame>
    <description>The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine</measure>
    <time_frame>Day 31 (1 month post vaccination)</time_frame>
    <description>The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.&#xD;
Fourfold increase is defined as- for subjects with a pre-vaccination titer &lt;1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.</measure>
    <time_frame>Day 91 (1 month post second vaccination)</time_frame>
    <description>The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.&#xD;
Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.&#xD;
Immune sufficiency was not applicable for M10713 strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</measure>
    <time_frame>Day 91 (1 month post second vaccination)</time_frame>
    <description>The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</measure>
    <time_frame>Day 91 (1 month post second vaccination)</time_frame>
    <description>The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</measure>
    <time_frame>Day 91 (1 month post second vaccination)</time_frame>
    <description>The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</measure>
    <time_frame>From day 1 to day 7 after vaccination</time_frame>
    <description>The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</measure>
    <time_frame>From day 1 to day 7 after vaccination</time_frame>
    <description>The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</measure>
    <time_frame>From day 1 to day 7 after any vaccination</time_frame>
    <description>The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</measure>
    <time_frame>From day 1 to study termination</time_frame>
    <description>The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</measure>
    <time_frame>From day 1 to study termination</time_frame>
    <description>The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Unsolicited AEs After Any Vaccination.</measure>
    <time_frame>From day 1 to study termination</time_frame>
    <description>The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.</description>
  </secondary_outcome>
  <number_of_arms>13</number_of_arms>
  <enrollment type="Actual">805</enrollment>
  <condition>Meningococcal Disease</condition>
  <condition>Meningococcal Meningitis</condition>
  <arm_group>
    <arm_group_label>B+R246_12_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B+R246_18_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B+R246_24_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B246_12_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B246_18_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B246_24_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B+R234_12_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B+R234_18_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B+R234_24_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B12 14_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 12 and14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B18 20_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 18 &amp; 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B24 26_48</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 24 &amp; 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B48_50</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine, two months apart, in the present study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine</intervention_name>
    <description>0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose</description>
    <arm_group_label>B+R234_12_48</arm_group_label>
    <arm_group_label>B+R234_18_48</arm_group_label>
    <arm_group_label>B+R234_24_48</arm_group_label>
    <arm_group_label>B+R246_12_48</arm_group_label>
    <arm_group_label>B+R246_18_48</arm_group_label>
    <arm_group_label>B+R246_24_48</arm_group_label>
    <arm_group_label>B12 14_48</arm_group_label>
    <arm_group_label>B18 20_48</arm_group_label>
    <arm_group_label>B24 26_48</arm_group_label>
    <arm_group_label>B246_12_48</arm_group_label>
    <arm_group_label>B246_18_48</arm_group_label>
    <arm_group_label>B246_24_48</arm_group_label>
    <other_name>rMenB+OMV NZ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine</intervention_name>
    <description>0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart</description>
    <arm_group_label>B48_50</arm_group_label>
    <other_name>rMenB+OMV NZ</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A. Inclusion Criteria for naïve subjects, newly enrolled (B48_50):&#xD;
&#xD;
          1. 4 years old (48 to 60 months) healthy male and female subjects will be recruited from&#xD;
             the same sites as in study V72P12E1. The age window is defined as the first day the&#xD;
             subject turns 4 years old up to the day before the subject turns 5 years old.&#xD;
&#xD;
          2. For whom parent/legal guardian(s) has given written informed consent after the nature&#xD;
             of the study has been explained.&#xD;
&#xD;
          3. For whom parent/legal guardian(s) confirmed availability for the visit(s) scheduled in&#xD;
             the study.&#xD;
&#xD;
          4. In good health as determined by medical history, physical examination, clinical&#xD;
             judgment of the investigator.&#xD;
&#xD;
        B. Inclusion Criteria for follow-on participants (Groups B+R246 12_48, B+R246 18_48, B+R246&#xD;
        24_48, B246 12_48, B246 18_48, B246 24_48, B+R234 12_48, B+R234 18_48, B+R234 24_48, B12&#xD;
        14_48, B18 20_48, B24 26_48):&#xD;
&#xD;
        Inclusion criteria are the same as for Group B48_50, with the addition that they are&#xD;
        subjects who completed the vaccination course of V72P12E1 study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A. Exclusion Criteria for naïve subjects, newly enrolled (Group 7):&#xD;
&#xD;
          1. Subjects whose parents/legal guardians are unwilling or unable to give written&#xD;
             informed consent to participate in the study.&#xD;
&#xD;
          2. History of any meningococcal B vaccine administration.&#xD;
&#xD;
          3. Previous ascertained or suspected disease caused by N. meningitidis.&#xD;
&#xD;
          4. Household contact with and/or intimate exposure to an individual with laboratory&#xD;
             confirmed N. meningitidis.&#xD;
&#xD;
          5. History of allergic reaction to any vaccine component.&#xD;
&#xD;
          6. Significant chronic infection.&#xD;
&#xD;
          7. Any serious chronic or progressive disease according to the judgment of the&#xD;
             investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic&#xD;
             disease, progressive neurological disease or seizure, either associated with fever or&#xD;
             as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV&#xD;
             infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure&#xD;
             or severe malnutrition).&#xD;
&#xD;
          8. Known or suspected impairment/alteration of the immune system resulting from (for&#xD;
             example) receipt of chronic immunosuppressive therapy or immunostimulants.&#xD;
&#xD;
          9. Participation in another clinical trial within 90 days prior to enrolment or planned&#xD;
             for during study.&#xD;
&#xD;
         10. Family members and household members of research staff.&#xD;
&#xD;
         11. Any condition which, in the opinion of the investigator, might interfere with the&#xD;
             evaluation of the study objectives.&#xD;
&#xD;
        B. Exclusion Criteria for follow-on participants ((Groups B+R246 12_48, B+R246 18_48,&#xD;
        B+R246 24_48, B246 12_48, B246 18_48, B246 24_48, B+R234 12_48, B+R234 18_48, B+R234 24_48,&#xD;
        B12 14_48, B18 20_48, B24 26_48):&#xD;
&#xD;
        Exclusion criteria are the same as for Group B48_50, with the exception of criterion 2 and&#xD;
        excluding participation in V72P12E1 for criterion 9.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>48 Months</minimum_age>
    <maximum_age>60 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Vaccines</last_name>
    <role>Study Chair</role>
    <affiliation>Novartis Vaccines</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Jaromer</city>
        <state>Alšova 466</state>
        <zip>55101</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Jaromer</city>
        <state>Dr. E.Beneše 191</state>
        <zip>55101</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Sezemice</city>
        <state>Havlickova 168</state>
        <zip>53304</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Hronov</city>
        <state>Hostovského 485</state>
        <zip>54931</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Ceska Skalice</city>
        <state>Husovo namesti 36</state>
        <zip>55203</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Pardubice</city>
        <state>L.Male 656</state>
        <zip>53012</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Hradec Králové</city>
        <state>Manesova 646</state>
        <zip>50002</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Hronov</city>
        <state>Palackeho 517</state>
        <zip>54931</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Hradec Králové</city>
        <state>Pardubicka 752</state>
        <zip>50004</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Chlumec nad Cidlinou</city>
        <state>Pernstynska 127/I</state>
        <zip>50351</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Náchod</name>
      <address>
        <city>Nachod</city>
        <state>Purkynova 446</state>
        <zip>54701</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <state>Ruských legií 352</state>
        <zip>37701</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Pardubice</city>
        <state>Sladkovskeho 2617</state>
        <zip>53002</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <state>Sídliste Vajgar 724/III</state>
        <zip>37701</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakulta vojenskeho zdravotnictvi UO</name>
      <address>
        <city>Hradec Kralove</city>
        <state>Trebesska 1575</state>
        <zip>50001</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Holice</city>
        <state>U kaplicky 1042</state>
        <zip>53401</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordinace praktickeho lekare pro deti a dorost</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <state>U nemocnice380/III</state>
        <zip>37701</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita di Firenze -Pediatria</name>
      <address>
        <city>Florence</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Cà Granda</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Maggiore della Carita</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dip Pediatria AO Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago de Compostela A Coruña</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir</name>
      <address>
        <city>Valencia</city>
        <zip>46020/46001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complexo Hospitalario Xeral Cies</name>
      <address>
        <city>Vigo Pontevedra</city>
        <zip>36204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <state>Headington</state>
        <zip>OX3 7LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Bristol NHS Trust</name>
      <address>
        <city>Bristol</city>
        <zip>BS1 3NU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter NHS Foundation Trust</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Georges Hospital</name>
      <address>
        <city>London</city>
        <zip>SW17 0RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czech Republic</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>October 1, 2014</results_first_submitted>
  <results_first_submitted_qc>December 29, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 13, 2015</results_first_posted>
  <last_update_submitted>December 29, 2014</last_update_submitted>
  <last_update_submitted_qc>December 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meningococcal disease, vaccines, children, persistence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningococcal Infections</mesh_term>
    <mesh_term>Meningitis, Meningococcal</mesh_term>
    <mesh_term>Meningitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled from 4 centers from the UK, 4 centers from Italy, 4 centers from Spain, 19 centers from Czech Republic.</recruitment_details>
      <pre_assignment_details>All subjects were included in the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>B+R246_12_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P2">
          <title>B+R246_18_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P3">
          <title>B+R246_24_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P4">
          <title>B246_12_48</title>
          <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P5">
          <title>B246_18_48</title>
          <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P6">
          <title>B246_24_48</title>
          <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P7">
          <title>B+R234_12_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P8">
          <title>B+R234_18_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P9">
          <title>B+R234_24_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P10">
          <title>B12 14_48</title>
          <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P11">
          <title>B18 20_48</title>
          <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P12">
          <title>B24 26_48</title>
          <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="P13">
          <title>B48_50</title>
          <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="60"/>
                <participants group_id="P4" count="66"/>
                <participants group_id="P5" count="64"/>
                <participants group_id="P6" count="55"/>
                <participants group_id="P7" count="43"/>
                <participants group_id="P8" count="29"/>
                <participants group_id="P9" count="28"/>
                <participants group_id="P10" count="100"/>
                <participants group_id="P11" count="11"/>
                <participants group_id="P12" count="12"/>
                <participants group_id="P13" count="209"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="59"/>
                <participants group_id="P4" count="66"/>
                <participants group_id="P5" count="63"/>
                <participants group_id="P6" count="54"/>
                <participants group_id="P7" count="41"/>
                <participants group_id="P8" count="28"/>
                <participants group_id="P9" count="26"/>
                <participants group_id="P10" count="99"/>
                <participants group_id="P11" count="11"/>
                <participants group_id="P12" count="12"/>
                <participants group_id="P13" count="190"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Father in hospital</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Anaysis was done on the all enrolled population, ie, all subjects who have signed an informed consent, undergone screening procedure(s) and were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>B+R246_12_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B2">
          <title>B+R246_18_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B3">
          <title>B+R246_24_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B4">
          <title>B246_12_48</title>
          <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B5">
          <title>B246_18_48</title>
          <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B6">
          <title>B246_24_48</title>
          <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B7">
          <title>B+R234_12_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B8">
          <title>B+R234_18_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B9">
          <title>B+R234_24_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B10">
          <title>B12 14_48</title>
          <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B11">
          <title>B18 20_48</title>
          <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B12">
          <title>B24 26_48</title>
          <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="B13">
          <title>B48 50</title>
          <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
        </group>
        <group group_id="B14">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="67"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="60"/>
            <count group_id="B4" value="66"/>
            <count group_id="B5" value="64"/>
            <count group_id="B6" value="55"/>
            <count group_id="B7" value="43"/>
            <count group_id="B8" value="29"/>
            <count group_id="B9" value="28"/>
            <count group_id="B10" value="100"/>
            <count group_id="B11" value="11"/>
            <count group_id="B12" value="12"/>
            <count group_id="B13" value="209"/>
            <count group_id="B14" value="805"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.8" spread="3.4"/>
                    <measurement group_id="B2" value="52.1" spread="3.4"/>
                    <measurement group_id="B3" value="51.7" spread="3.5"/>
                    <measurement group_id="B4" value="51.7" spread="3.5"/>
                    <measurement group_id="B5" value="51.3" spread="3.7"/>
                    <measurement group_id="B6" value="52.3" spread="3.7"/>
                    <measurement group_id="B7" value="51.8" spread="3.4"/>
                    <measurement group_id="B8" value="51.4" spread="3.4"/>
                    <measurement group_id="B9" value="53.1" spread="3.5"/>
                    <measurement group_id="B10" value="51.7" spread="3.3"/>
                    <measurement group_id="B11" value="53.4" spread="4.3"/>
                    <measurement group_id="B12" value="56.8" spread="1.5"/>
                    <measurement group_id="B13" value="53.7" spread="3.6"/>
                    <measurement group_id="B14" value="52.4" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="32"/>
                    <measurement group_id="B6" value="30"/>
                    <measurement group_id="B7" value="24"/>
                    <measurement group_id="B8" value="17"/>
                    <measurement group_id="B9" value="13"/>
                    <measurement group_id="B10" value="50"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="4"/>
                    <measurement group_id="B13" value="99"/>
                    <measurement group_id="B14" value="387"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="32"/>
                    <measurement group_id="B6" value="25"/>
                    <measurement group_id="B7" value="19"/>
                    <measurement group_id="B8" value="12"/>
                    <measurement group_id="B9" value="15"/>
                    <measurement group_id="B10" value="50"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="8"/>
                    <measurement group_id="B13" value="110"/>
                    <measurement group_id="B14" value="418"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules</title>
        <description>The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.&#xD;
The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).</description>
        <time_frame>Day 1 (24-36 months post booster; baseline for naive)</time_frame>
        <population>Full Analysis Set (Fas), Persistency: All subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1). Persistence data sets include nonvaccination and vaccination subsets of subjects from different groups with different primary vaccination schedules of MenB+Routine vaccines and routine vaccines.</population>
        <group_list>
          <group group_id="O1">
            <title>B+R246_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B+R246_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B+R246_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B246_12_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O5">
            <title>B246_18_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O6">
            <title>B246_24_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O7">
            <title>B+R234_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O8">
            <title>B+R234_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O9">
            <title>B+R234_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O10">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules</title>
          <description>The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.&#xD;
The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).</description>
          <population>Full Analysis Set (Fas), Persistency: All subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1). Persistence data sets include nonvaccination and vaccination subsets of subjects from different groups with different primary vaccination schedules of MenB+Routine vaccines and routine vaccines.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="66"/>
                <count group_id="O5" value="63"/>
                <count group_id="O6" value="54"/>
                <count group_id="O7" value="42"/>
                <count group_id="O8" value="28"/>
                <count group_id="O9" value="28"/>
                <count group_id="O10" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,206</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="5" upper_limit="22"/>
                    <measurement group_id="O2" value="18" lower_limit="10" upper_limit="30"/>
                    <measurement group_id="O3" value="24" lower_limit="14" upper_limit="37"/>
                    <measurement group_id="O4" value="20" lower_limit="11" upper_limit="32"/>
                    <measurement group_id="O5" value="27" lower_limit="17" upper_limit="40"/>
                    <measurement group_id="O6" value="35" lower_limit="23" upper_limit="49"/>
                    <measurement group_id="O7" value="12" lower_limit="4" upper_limit="26"/>
                    <measurement group_id="O8" value="25" lower_limit="11" upper_limit="45"/>
                    <measurement group_id="O9" value="21" lower_limit="8" upper_limit="41"/>
                    <measurement group_id="O10" value="0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,200</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" lower_limit="83" upper_limit="98"/>
                    <measurement group_id="O2" value="98" lower_limit="91" upper_limit="100"/>
                    <measurement group_id="O3" value="97" lower_limit="88" upper_limit="100"/>
                    <measurement group_id="O4" value="97" lower_limit="89" upper_limit="100"/>
                    <measurement group_id="O5" value="100" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="93" upper_limit="100"/>
                    <measurement group_id="O7" value="90" lower_limit="77" upper_limit="97"/>
                    <measurement group_id="O8" value="89" lower_limit="72" upper_limit="98"/>
                    <measurement group_id="O9" value="96" lower_limit="82" upper_limit="100"/>
                    <measurement group_id="O10" value="5" lower_limit="2" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 - ≥ 1:5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="3" upper_limit="18"/>
                    <measurement group_id="O2" value="8" lower_limit="3" upper_limit="18"/>
                    <measurement group_id="O3" value="12" lower_limit="5" upper_limit="23"/>
                    <measurement group_id="O4" value="9" lower_limit="3" upper_limit="19"/>
                    <measurement group_id="O5" value="11" lower_limit="5" upper_limit="22"/>
                    <measurement group_id="O6" value="9" lower_limit="3" upper_limit="20"/>
                    <measurement group_id="O7" value="10" lower_limit="3" upper_limit="23"/>
                    <measurement group_id="O8" value="11" lower_limit="2" upper_limit="28"/>
                    <measurement group_id="O9" value="11" lower_limit="2" upper_limit="28"/>
                    <measurement group_id="O10" value="0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54" lower_limit="41" upper_limit="66"/>
                    <measurement group_id="O2" value="68" lower_limit="54" upper_limit="79"/>
                    <measurement group_id="O3" value="74" lower_limit="61" upper_limit="85"/>
                    <measurement group_id="O4" value="55" lower_limit="42" upper_limit="68"/>
                    <measurement group_id="O5" value="53" lower_limit="40" upper_limit="66"/>
                    <measurement group_id="O6" value="80" lower_limit="66" upper_limit="89"/>
                    <measurement group_id="O7" value="68" lower_limit="51" upper_limit="81"/>
                    <measurement group_id="O8" value="75" lower_limit="55" upper_limit="89"/>
                    <measurement group_id="O9" value="75" lower_limit="55" upper_limit="89"/>
                    <measurement group_id="O10" value="60" lower_limit="53" upper_limit="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,206</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="2" upper_limit="17"/>
                    <measurement group_id="O2" value="10" lower_limit="4" upper_limit="21"/>
                    <measurement group_id="O3" value="17" lower_limit="8" upper_limit="29"/>
                    <measurement group_id="O4" value="11" lower_limit="4" upper_limit="21"/>
                    <measurement group_id="O5" value="24" lower_limit="14" upper_limit="36"/>
                    <measurement group_id="O6" value="28" lower_limit="16" upper_limit="42"/>
                    <measurement group_id="O7" value="7" lower_limit="1" upper_limit="19"/>
                    <measurement group_id="O8" value="21" lower_limit="8" upper_limit="41"/>
                    <measurement group_id="O9" value="21" lower_limit="8" upper_limit="41"/>
                    <measurement group_id="O10" value="0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,200</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91" lower_limit="82" upper_limit="97"/>
                    <measurement group_id="O2" value="97" lower_limit="88" upper_limit="100"/>
                    <measurement group_id="O3" value="93" lower_limit="83" upper_limit="98"/>
                    <measurement group_id="O4" value="94" lower_limit="85" upper_limit="98"/>
                    <measurement group_id="O5" value="94" lower_limit="84" upper_limit="98"/>
                    <measurement group_id="O6" value="100" lower_limit="93" upper_limit="100"/>
                    <measurement group_id="O7" value="90" lower_limit="77" upper_limit="97"/>
                    <measurement group_id="O8" value="86" lower_limit="67" upper_limit="96"/>
                    <measurement group_id="O9" value="96" lower_limit="82" upper_limit="100"/>
                    <measurement group_id="O10" value="3" lower_limit="1" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 - ≥ 1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="1" upper_limit="13"/>
                    <measurement group_id="O2" value="5" lower_limit="1" upper_limit="14"/>
                    <measurement group_id="O3" value="8" lower_limit="3" upper_limit="18"/>
                    <measurement group_id="O4" value="8" lower_limit="3" upper_limit="17"/>
                    <measurement group_id="O5" value="3" lower_limit="0" upper_limit="11"/>
                    <measurement group_id="O6" value="4" lower_limit="0" upper_limit="13"/>
                    <measurement group_id="O7" value="2" lower_limit="0.06" upper_limit="13"/>
                    <measurement group_id="O8" value="7" lower_limit="1" upper_limit="24"/>
                    <measurement group_id="O9" value="11" lower_limit="2" upper_limit="28"/>
                    <measurement group_id="O10" value="0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" lower_limit="37" upper_limit="62"/>
                    <measurement group_id="O2" value="53" lower_limit="39" upper_limit="66"/>
                    <measurement group_id="O3" value="60" lower_limit="47" upper_limit="73"/>
                    <measurement group_id="O4" value="48" lower_limit="35" upper_limit="61"/>
                    <measurement group_id="O5" value="45" lower_limit="32" upper_limit="58"/>
                    <measurement group_id="O6" value="65" lower_limit="51" upper_limit="77"/>
                    <measurement group_id="O7" value="60" lower_limit="43" upper_limit="75"/>
                    <measurement group_id="O8" value="61" lower_limit="41" upper_limit="78"/>
                    <measurement group_id="O9" value="61" lower_limit="41" upper_limit="78"/>
                    <measurement group_id="O10" value="56" lower_limit="48" upper_limit="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules</title>
        <description>The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).</description>
        <time_frame>Day 1 (24-36 months post booster; baseline for naive)</time_frame>
        <population>FAS, Persistency.</population>
        <group_list>
          <group group_id="O1">
            <title>B+R246_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B+R246_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B+R246_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B246_12_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O5">
            <title>B246_18_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O6">
            <title>B246_24_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O7">
            <title>B+R234_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O8">
            <title>B+R234_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O9">
            <title>B+R234_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O10">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules</title>
          <description>The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).</description>
          <population>FAS, Persistency.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="66"/>
                <count group_id="O5" value="63"/>
                <count group_id="O6" value="54"/>
                <count group_id="O7" value="42"/>
                <count group_id="O8" value="28"/>
                <count group_id="O9" value="28"/>
                <count group_id="O10" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76; N=67,60,59,65,63,54,42,28,28,206</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.75" lower_limit="1.36" upper_limit="2.25"/>
                    <measurement group_id="O2" value="1.68" lower_limit="1.29" upper_limit="2.19"/>
                    <measurement group_id="O3" value="2.41" lower_limit="1.83" upper_limit="3.19"/>
                    <measurement group_id="O4" value="1.72" lower_limit="1.29" upper_limit="2.29"/>
                    <measurement group_id="O5" value="1.99" lower_limit="1.49" upper_limit="2.65"/>
                    <measurement group_id="O6" value="2.69" lower_limit="1.96" upper_limit="3.7"/>
                    <measurement group_id="O7" value="1.51" lower_limit="1.04" upper_limit="2.18"/>
                    <measurement group_id="O8" value="2.2" lower_limit="1.38" upper_limit="3.49"/>
                    <measurement group_id="O9" value="2.2" lower_limit="1.37" upper_limit="3.53"/>
                    <measurement group_id="O10" value="1.04" lower_limit="1.01" upper_limit="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99; N=67,60,58,64,62,54,42,28,28,200</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" lower_limit="27" upper_limit="48"/>
                    <measurement group_id="O2" value="69" lower_limit="50" upper_limit="94"/>
                    <measurement group_id="O3" value="69" lower_limit="50" upper_limit="96"/>
                    <measurement group_id="O4" value="59" lower_limit="45" upper_limit="78"/>
                    <measurement group_id="O5" value="57" lower_limit="43" upper_limit="75"/>
                    <measurement group_id="O6" value="111" lower_limit="82" upper_limit="151"/>
                    <measurement group_id="O7" value="52" lower_limit="34" upper_limit="81"/>
                    <measurement group_id="O8" value="62" lower_limit="36" upper_limit="108"/>
                    <measurement group_id="O9" value="101" lower_limit="57" upper_limit="177"/>
                    <measurement group_id="O10" value="1.15" lower_limit="1.05" upper_limit="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" lower_limit="1.03" upper_limit="1.52"/>
                    <measurement group_id="O2" value="1.29" lower_limit="1.05" upper_limit="1.59"/>
                    <measurement group_id="O3" value="1.38" lower_limit="1.11" upper_limit="1.72"/>
                    <measurement group_id="O4" value="1.48" lower_limit="1.2" upper_limit="1.83"/>
                    <measurement group_id="O5" value="1.34" lower_limit="1.08" upper_limit="1.66"/>
                    <measurement group_id="O6" value="1.52" lower_limit="1.2" upper_limit="1.92"/>
                    <measurement group_id="O7" value="1.32" lower_limit="1.05" upper_limit="1.65"/>
                    <measurement group_id="O8" value="1.25" lower_limit="0.94" upper_limit="1.66"/>
                    <measurement group_id="O9" value="1.62" lower_limit="1.21" upper_limit="2.16"/>
                    <measurement group_id="O10" value="1.01" lower_limit="0.99" upper_limit="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713; N=65,59,58,62,60,54,40,28,28,192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.14" lower_limit="4.19" upper_limit="8.99"/>
                    <measurement group_id="O2" value="7.36" lower_limit="4.94" upper_limit="11"/>
                    <measurement group_id="O3" value="9.08" lower_limit="5.97" upper_limit="14"/>
                    <measurement group_id="O4" value="7.86" lower_limit="5.17" upper_limit="12"/>
                    <measurement group_id="O5" value="7.77" lower_limit="5.07" upper_limit="12"/>
                    <measurement group_id="O6" value="15" lower_limit="9.49" upper_limit="24"/>
                    <measurement group_id="O7" value="9.61" lower_limit="5.81" upper_limit="16"/>
                    <measurement group_id="O8" value="11" lower_limit="5.92" upper_limit="20"/>
                    <measurement group_id="O9" value="11" lower_limit="5.9" upper_limit="21"/>
                    <measurement group_id="O10" value="8.75" lower_limit="6.74" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules</title>
        <description>The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.</description>
        <time_frame>Day 1 (24-36 months post booster dose; baseline for naive)</time_frame>
        <population>FAS, Persistency.</population>
        <group_list>
          <group group_id="O1">
            <title>B+R246_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B+R246_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B+R246_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B246_12_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O5">
            <title>B246_18_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O6">
            <title>B246_24_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O7">
            <title>B+R234_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O8">
            <title>B+R234_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O9">
            <title>B+R234_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules</title>
          <description>The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.</description>
          <population>FAS, Persistency.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="56"/>
                <count group_id="O6" value="47"/>
                <count group_id="O7" value="39"/>
                <count group_id="O8" value="28"/>
                <count group_id="O9" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76; N=62,56,52,57,55,46,38,27,25,206</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.012" lower_limit="0.0091" upper_limit="0.017"/>
                    <measurement group_id="O2" value="0.013" lower_limit="0.0096" upper_limit="0.018"/>
                    <measurement group_id="O3" value="0.023" lower_limit="0.016" upper_limit="0.033"/>
                    <measurement group_id="O4" value="0.0092" lower_limit="0.0066" upper_limit="0.013"/>
                    <measurement group_id="O5" value="0.013" lower_limit="0.0097" upper_limit="0.018"/>
                    <measurement group_id="O6" value="0.023" lower_limit="0.016" upper_limit="0.033"/>
                    <measurement group_id="O7" value="0.0091" lower_limit="0.0064" upper_limit="0.013"/>
                    <measurement group_id="O8" value="0.023" lower_limit="0.015" upper_limit="0.036"/>
                    <measurement group_id="O9" value="0.023" lower_limit="0.014" upper_limit="0.036"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99; N=61,57,50,57,55,44,37,27,25,200</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.029" lower_limit="0.023" upper_limit="0.037"/>
                    <measurement group_id="O2" value="0.032" lower_limit="0.026" upper_limit="0.041"/>
                    <measurement group_id="O3" value="0.043" lower_limit="0.033" upper_limit="0.056"/>
                    <measurement group_id="O4" value="0.031" lower_limit="0.024" upper_limit="0.041"/>
                    <measurement group_id="O5" value="0.034" lower_limit="0.026" upper_limit="0.045"/>
                    <measurement group_id="O6" value="0.054" lower_limit="0.04" upper_limit="0.074"/>
                    <measurement group_id="O7" value="0.035" lower_limit="0.026" upper_limit="0.048"/>
                    <measurement group_id="O8" value="0.037" lower_limit="0.025" upper_limit="0.054"/>
                    <measurement group_id="O9" value="0.055" lower_limit="0.037" upper_limit="0.081"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.028" lower_limit="0.021" upper_limit="0.039"/>
                    <measurement group_id="O2" value="0.094" lower_limit="0.067" upper_limit="0.13"/>
                    <measurement group_id="O3" value="0.071" lower_limit="0.05" upper_limit="0.1"/>
                    <measurement group_id="O4" value="0.043" lower_limit="0.031" upper_limit="0.06"/>
                    <measurement group_id="O5" value="0.081" lower_limit="0.058" upper_limit="0.11"/>
                    <measurement group_id="O6" value="0.11" lower_limit="0.075" upper_limit="0.16"/>
                    <measurement group_id="O7" value="0.03" lower_limit="0.02" upper_limit="0.044"/>
                    <measurement group_id="O8" value="0.082" lower_limit="0.05" upper_limit="0.14"/>
                    <measurement group_id="O9" value="0.066" lower_limit="0.038" upper_limit="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713; N=26,24,25</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.</measurement>
                    <measurement group_id="O5" value="NA" lower_limit="NA" upper_limit="NA">GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.</measurement>
                    <measurement group_id="O6" value="NA" lower_limit="NA" upper_limit="NA">GMTs were not calculated for this group in the parent study therefore the ratios cannot be available.</measurement>
                    <measurement group_id="O7" value="0.67" lower_limit="0.32" upper_limit="1.4"/>
                    <measurement group_id="O8" value="0.91" lower_limit="0.4" upper_limit="2.05"/>
                    <measurement group_id="O9" value="0.47" lower_limit="0.21" upper_limit="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules</title>
        <description>The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.</description>
        <time_frame>Day 1 (22-34 months post last MenB vaccine)</time_frame>
        <population>FAS, Persistency. Note: Reporting groups in this endpoint and in endpoints 5 and 6 received vaccination according to different schedules with respect to the groups reported in endpoints 1, 2 and 3.</population>
        <group_list>
          <group group_id="O1">
            <title>B12 14_48</title>
            <description>Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B18 20_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B24 26_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules</title>
          <description>The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.</description>
          <population>FAS, Persistency. Note: Reporting groups in this endpoint and in endpoints 5 and 6 received vaccination according to different schedules with respect to the groups reported in endpoints 1, 2 and 3.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA≥ 1:5 (H44/76 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="6" upper_limit="20"/>
                    <measurement group_id="O2" value="9" lower_limit="0" upper_limit="41"/>
                    <measurement group_id="O3" value="9" lower_limit="0" upper_limit="41"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:5 (5/99 strain; N=96,11,11,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" lower_limit="76" upper_limit="91"/>
                    <measurement group_id="O2" value="100" lower_limit="72" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="72" upper_limit="100"/>
                    <measurement group_id="O4" value="5" lower_limit="2" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:5 (NZ 98/254 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="9"/>
                    <measurement group_id="O2" value="18" lower_limit="2" upper_limit="52"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="28"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:5 (M10713 strain; N=96,10,10,192)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59" lower_limit="49" upper_limit="69"/>
                    <measurement group_id="O2" value="60" lower_limit="26" upper_limit="88"/>
                    <measurement group_id="O3" value="60" lower_limit="26" upper_limit="88"/>
                    <measurement group_id="O4" value="60" lower_limit="53" upper_limit="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (H44/76 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="4" upper_limit="16"/>
                    <measurement group_id="O2" value="9" lower_limit="0" upper_limit="41"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="28"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (5/99 strain; N=96,11,11,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81" lower_limit="72" upper_limit="88"/>
                    <measurement group_id="O2" value="100" lower_limit="72" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="72" upper_limit="100"/>
                    <measurement group_id="O4" value="3" lower_limit="1" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (NZ 98/254 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="7"/>
                    <measurement group_id="O2" value="18" lower_limit="2" upper_limit="52"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="28"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (M10713 strain; N=96,10,10,192)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" lower_limit="39" upper_limit="59"/>
                    <measurement group_id="O2" value="40" lower_limit="12" upper_limit="74"/>
                    <measurement group_id="O3" value="60" lower_limit="26" upper_limit="88"/>
                    <measurement group_id="O4" value="56" lower_limit="48" upper_limit="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules</title>
        <description>The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.</description>
        <time_frame>Day 1 (22-36 months post last MenB vaccine; baseline for naive)</time_frame>
        <population>FAS, Persistency.</population>
        <group_list>
          <group group_id="O1">
            <title>B12 14_48</title>
            <description>Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B18 20_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B24 26_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules</title>
          <description>The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.</description>
          <population>FAS, Persistency.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.61" lower_limit="1.3" upper_limit="2"/>
                    <measurement group_id="O2" value="2.03" lower_limit="1.11" upper_limit="3.72"/>
                    <measurement group_id="O3" value="1.69" lower_limit="0.91" upper_limit="3.12"/>
                    <measurement group_id="O4" value="1.04" lower_limit="1.01" upper_limit="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain; N=96, 11, 11, 200</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" lower_limit="17" upper_limit="32"/>
                    <measurement group_id="O2" value="47" lower_limit="20" upper_limit="112"/>
                    <measurement group_id="O3" value="69" lower_limit="29" upper_limit="165"/>
                    <measurement group_id="O4" value="1.15" lower_limit="1.05" upper_limit="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" lower_limit="0.96" upper_limit="1.37"/>
                    <measurement group_id="O2" value="2.68" lower_limit="1.65" upper_limit="4.36"/>
                    <measurement group_id="O3" value="1.06" lower_limit="0.65" upper_limit="1.75"/>
                    <measurement group_id="O4" value="1.01" lower_limit="0.99" upper_limit="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=96, 10, 10, 192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.83" lower_limit="5.54" upper_limit="11"/>
                    <measurement group_id="O2" value="9.67" lower_limit="3.54" upper_limit="26"/>
                    <measurement group_id="O3" value="8.4" lower_limit="3.03" upper_limit="23"/>
                    <measurement group_id="O4" value="8.75" lower_limit="6.74" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules</title>
        <description>The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.</description>
        <time_frame>Day 1 (22-34 months post last MenB vaccine)</time_frame>
        <population>FAS, Persistency.</population>
        <group_list>
          <group group_id="O1">
            <title>B12 14_48</title>
            <description>Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B18 20_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B24 26_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules</title>
          <description>The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.</description>
          <population>FAS, Persistency.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.092" lower_limit="0.069" upper_limit="0.12"/>
                    <measurement group_id="O2" value="0.18" lower_limit="0.078" upper_limit="0.43"/>
                    <measurement group_id="O3" value="0.2" lower_limit="0.086" upper_limit="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" lower_limit="0.34" upper_limit="0.59"/>
                    <measurement group_id="O2" value="1.9" lower_limit="0.84" upper_limit="4.29"/>
                    <measurement group_id="O3" value="1.36" lower_limit="0.62" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=88, 9, 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" lower_limit="0.21" upper_limit="0.37"/>
                    <measurement group_id="O2" value="0.73" lower_limit="0.32" upper_limit="1.68"/>
                    <measurement group_id="O3" value="0.42" lower_limit="0.17" upper_limit="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=7, 7, 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="3.34" upper_limit="38"/>
                    <measurement group_id="O2" value="6.05" lower_limit="1.45" upper_limit="25"/>
                    <measurement group_id="O3" value="6.88" lower_limit="1.68" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</title>
        <description>The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.</description>
        <time_frame>Day 31 (1 month post vaccination)</time_frame>
        <population>Analysis was done on FAS, Immunogenicity, ie, all subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>B+R246_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B+R246_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B+R246_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B246_12_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O5">
            <title>B246_18_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O6">
            <title>B246_24_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O7">
            <title>B+R234_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O8">
            <title>B+R234_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O9">
            <title>B+R234_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O10">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</title>
          <description>The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.</description>
          <population>Analysis was done on FAS, Immunogenicity, ie, all subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="15"/>
                <count group_id="O7" value="40"/>
                <count group_id="O8" value="26"/>
                <count group_id="O9" value="26"/>
                <count group_id="O10" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="81" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O5" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="78" upper_limit="100"/>
                    <measurement group_id="O7" value="97" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O8" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O9" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O10" value="71" lower_limit="64" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="81" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O5" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="78" upper_limit="100"/>
                    <measurement group_id="O7" value="100" lower_limit="91" upper_limit="100"/>
                    <measurement group_id="O8" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O9" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O10" value="90" lower_limit="85" upper_limit="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,173</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" lower_limit="75" upper_limit="99"/>
                    <measurement group_id="O2" value="83" lower_limit="59" upper_limit="96"/>
                    <measurement group_id="O3" value="94" lower_limit="70" upper_limit="100"/>
                    <measurement group_id="O4" value="81" lower_limit="54" upper_limit="96"/>
                    <measurement group_id="O5" value="88" lower_limit="70" upper_limit="98"/>
                    <measurement group_id="O6" value="80" lower_limit="52" upper_limit="96"/>
                    <measurement group_id="O7" value="95" lower_limit="83" upper_limit="99"/>
                    <measurement group_id="O8" value="92" lower_limit="75" upper_limit="99"/>
                    <measurement group_id="O9" value="92" lower_limit="75" upper_limit="99"/>
                    <measurement group_id="O10" value="24" lower_limit="18" upper_limit="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,167</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" lower_limit="64" upper_limit="95"/>
                    <measurement group_id="O2" value="89" lower_limit="65" upper_limit="99"/>
                    <measurement group_id="O3" value="88" lower_limit="62" upper_limit="98"/>
                    <measurement group_id="O4" value="93" lower_limit="66" upper_limit="100"/>
                    <measurement group_id="O5" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O6" value="93" lower_limit="68" upper_limit="100"/>
                    <measurement group_id="O7" value="97" lower_limit="85" upper_limit="100"/>
                    <measurement group_id="O8" value="100" lower_limit="86" upper_limit="100"/>
                    <measurement group_id="O9" value="100" lower_limit="86" upper_limit="100"/>
                    <measurement group_id="O10" value="77" lower_limit="70" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,175</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="81" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O5" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="78" upper_limit="100"/>
                    <measurement group_id="O7" value="97" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O8" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O9" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O10" value="63" lower_limit="55" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="81" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O5" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="78" upper_limit="100"/>
                    <measurement group_id="O7" value="100" lower_limit="91" upper_limit="100"/>
                    <measurement group_id="O8" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O9" value="100" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O10" value="87" lower_limit="81" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,173</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" lower_limit="65" upper_limit="96"/>
                    <measurement group_id="O2" value="61" lower_limit="36" upper_limit="83"/>
                    <measurement group_id="O3" value="81" lower_limit="54" upper_limit="96"/>
                    <measurement group_id="O4" value="75" lower_limit="48" upper_limit="93"/>
                    <measurement group_id="O5" value="88" lower_limit="70" upper_limit="98"/>
                    <measurement group_id="O6" value="80" lower_limit="52" upper_limit="96"/>
                    <measurement group_id="O7" value="88" lower_limit="73" upper_limit="96"/>
                    <measurement group_id="O8" value="81" lower_limit="61" upper_limit="93"/>
                    <measurement group_id="O9" value="88" lower_limit="70" upper_limit="98"/>
                    <measurement group_id="O10" value="17" lower_limit="12" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,167</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" lower_limit="55" upper_limit="91"/>
                    <measurement group_id="O2" value="89" lower_limit="65" upper_limit="99"/>
                    <measurement group_id="O3" value="88" lower_limit="62" upper_limit="98"/>
                    <measurement group_id="O4" value="93" lower_limit="66" upper_limit="100"/>
                    <measurement group_id="O5" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O6" value="93" lower_limit="68" upper_limit="100"/>
                    <measurement group_id="O7" value="97" lower_limit="85" upper_limit="100"/>
                    <measurement group_id="O8" value="100" lower_limit="86" upper_limit="100"/>
                    <measurement group_id="O9" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O10" value="74" lower_limit="67" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</title>
        <description>The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.</description>
        <time_frame>Day 31 (1 month post vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B+R246_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B+R246_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B+R246_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B246_12_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O5">
            <title>B246_18_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O6">
            <title>B246_24_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O7">
            <title>B+R234_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O8">
            <title>B+R234_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O9">
            <title>B+R234_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O10">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</title>
          <description>The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="15"/>
                <count group_id="O7" value="40"/>
                <count group_id="O8" value="26"/>
                <count group_id="O9" value="26"/>
                <count group_id="O10" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain; N=26,18,16,16,26,15,39,26,26,175</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108" lower_limit="70" upper_limit="168"/>
                    <measurement group_id="O2" value="115" lower_limit="68" upper_limit="195"/>
                    <measurement group_id="O3" value="107" lower_limit="61" upper_limit="188"/>
                    <measurement group_id="O4" value="173" lower_limit="98" upper_limit="303"/>
                    <measurement group_id="O5" value="191" lower_limit="123" upper_limit="297"/>
                    <measurement group_id="O6" value="212" lower_limit="119" upper_limit="379"/>
                    <measurement group_id="O7" value="167" lower_limit="109" upper_limit="258"/>
                    <measurement group_id="O8" value="146" lower_limit="85" upper_limit="251"/>
                    <measurement group_id="O9" value="135" lower_limit="78" upper_limit="235"/>
                    <measurement group_id="O10" value="11" lower_limit="8.51" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain; N=26,18,16,16,26,15,38,26,26,171</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="754" lower_limit="478" upper_limit="1190"/>
                    <measurement group_id="O2" value="1719" lower_limit="993" upper_limit="2976"/>
                    <measurement group_id="O3" value="933" lower_limit="518" upper_limit="1682"/>
                    <measurement group_id="O4" value="1959" lower_limit="1091" upper_limit="3517"/>
                    <measurement group_id="O5" value="1387" lower_limit="878" upper_limit="2191"/>
                    <measurement group_id="O6" value="1954" lower_limit="1068" upper_limit="3575"/>
                    <measurement group_id="O7" value="1711" lower_limit="1186" upper_limit="2470"/>
                    <measurement group_id="O8" value="1239" lower_limit="787" upper_limit="1953"/>
                    <measurement group_id="O9" value="1280" lower_limit="803" upper_limit="2041"/>
                    <measurement group_id="O10" value="34" lower_limit="27" upper_limit="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,173</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="13" upper_limit="36"/>
                    <measurement group_id="O2" value="11" lower_limit="5.66" upper_limit="20"/>
                    <measurement group_id="O3" value="28" lower_limit="14" upper_limit="55"/>
                    <measurement group_id="O4" value="16" lower_limit="8.2" upper_limit="31"/>
                    <measurement group_id="O5" value="21" lower_limit="13" upper_limit="36"/>
                    <measurement group_id="O6" value="15" lower_limit="7.66" upper_limit="31"/>
                    <measurement group_id="O7" value="26" lower_limit="18" upper_limit="36"/>
                    <measurement group_id="O8" value="18" lower_limit="12" upper_limit="28"/>
                    <measurement group_id="O9" value="27" lower_limit="18" upper_limit="42"/>
                    <measurement group_id="O10" value="2.25" lower_limit="1.84" upper_limit="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=25,18,16,14,25,15,36,25,25,167</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="13" upper_limit="37"/>
                    <measurement group_id="O2" value="19" lower_limit="10" upper_limit="36"/>
                    <measurement group_id="O3" value="28" lower_limit="14" upper_limit="54"/>
                    <measurement group_id="O4" value="32" lower_limit="16" upper_limit="65"/>
                    <measurement group_id="O5" value="37" lower_limit="22" upper_limit="63"/>
                    <measurement group_id="O6" value="33" lower_limit="17" upper_limit="64"/>
                    <measurement group_id="O7" value="53" lower_limit="40" upper_limit="71"/>
                    <measurement group_id="O8" value="58" lower_limit="40" upper_limit="84"/>
                    <measurement group_id="O9" value="51" lower_limit="35" upper_limit="73"/>
                    <measurement group_id="O10" value="20" lower_limit="15" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</title>
        <description>The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.</description>
        <time_frame>Day 31 (1 month post vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B+R246_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B+R246_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B+R246_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B246_12_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O5">
            <title>B246_18_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O6">
            <title>B246_24_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O7">
            <title>B+R234_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O8">
            <title>B+R234_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O9">
            <title>B+R234_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O10">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</title>
          <description>The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="15"/>
                <count group_id="O7" value="40"/>
                <count group_id="O8" value="25"/>
                <count group_id="O9" value="26"/>
                <count group_id="O10" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain; N=26,18,16,16,26,15,39,25,26,175</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="40" upper_limit="92"/>
                    <measurement group_id="O2" value="72" lower_limit="44" upper_limit="120"/>
                    <measurement group_id="O3" value="41" lower_limit="24" upper_limit="71"/>
                    <measurement group_id="O4" value="77" lower_limit="45" upper_limit="132"/>
                    <measurement group_id="O5" value="88" lower_limit="58" upper_limit="134"/>
                    <measurement group_id="O6" value="46" lower_limit="26" upper_limit="80"/>
                    <measurement group_id="O7" value="109" lower_limit="71" upper_limit="167"/>
                    <measurement group_id="O8" value="63" lower_limit="37" upper_limit="108"/>
                    <measurement group_id="O9" value="64" lower_limit="37" upper_limit="110"/>
                    <measurement group_id="O10" value="10" lower_limit="8.2" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain; N=26,18,16,15,25,15,38,25,26,168</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32" lower_limit="22" upper_limit="47"/>
                    <measurement group_id="O2" value="23" lower_limit="15" upper_limit="36"/>
                    <measurement group_id="O3" value="15" lower_limit="9.45" upper_limit="25"/>
                    <measurement group_id="O4" value="30" lower_limit="18" upper_limit="49"/>
                    <measurement group_id="O5" value="20" lower_limit="13" upper_limit="29"/>
                    <measurement group_id="O6" value="18" lower_limit="11" upper_limit="29"/>
                    <measurement group_id="O7" value="33" lower_limit="23" upper_limit="49"/>
                    <measurement group_id="O8" value="20" lower_limit="12" upper_limit="32"/>
                    <measurement group_id="O9" value="12" lower_limit="7.16" upper_limit="19"/>
                    <measurement group_id="O10" value="29" lower_limit="23" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="10" upper_limit="29"/>
                    <measurement group_id="O2" value="10" lower_limit="5.43" upper_limit="19"/>
                    <measurement group_id="O3" value="19" lower_limit="9.54" upper_limit="37"/>
                    <measurement group_id="O4" value="8.93" lower_limit="4.57" upper_limit="17"/>
                    <measurement group_id="O5" value="17" lower_limit="10" upper_limit="29"/>
                    <measurement group_id="O6" value="13" lower_limit="6.48" upper_limit="26"/>
                    <measurement group_id="O7" value="19" lower_limit="14" upper_limit="27"/>
                    <measurement group_id="O8" value="14" lower_limit="9.35" upper_limit="22"/>
                    <measurement group_id="O9" value="17" lower_limit="11" upper_limit="26"/>
                    <measurement group_id="O10" value="2.25" lower_limit="1.84" upper_limit="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=24,17,16,12,23,15,35,24,25,158</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.15" lower_limit="1.81" upper_limit="5.48"/>
                    <measurement group_id="O2" value="4.46" lower_limit="2.31" upper_limit="8.6"/>
                    <measurement group_id="O3" value="3.36" lower_limit="1.69" upper_limit="6.7"/>
                    <measurement group_id="O4" value="3.49" lower_limit="1.58" upper_limit="7.7"/>
                    <measurement group_id="O5" value="3.74" lower_limit="2.12" upper_limit="6.59"/>
                    <measurement group_id="O6" value="4.21" lower_limit="2.08" upper_limit="8.51"/>
                    <measurement group_id="O7" value="5.35" lower_limit="3.48" upper_limit="8.21"/>
                    <measurement group_id="O8" value="3.86" lower_limit="2.23" upper_limit="6.66"/>
                    <measurement group_id="O9" value="4.04" lower_limit="2.35" upper_limit="6.94"/>
                    <measurement group_id="O10" value="2" lower_limit="1.62" upper_limit="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</title>
        <description>The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.</description>
        <time_frame>Day 31 (1 month post vaccination)</time_frame>
        <population>Analysis was done on FAS, Immunogenicity.</population>
        <group_list>
          <group group_id="O1">
            <title>B+R246_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B+R246_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B+R246_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B246_12_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O5">
            <title>B246_18_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O6">
            <title>B246_24_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O7">
            <title>B+R234_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O8">
            <title>B+R234_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O9">
            <title>B+R234_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O10">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules</title>
          <description>The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.</description>
          <population>Analysis was done on FAS, Immunogenicity.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="15"/>
                <count group_id="O7" value="40"/>
                <count group_id="O8" value="25"/>
                <count group_id="O9" value="26"/>
                <count group_id="O10" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain; N=26,18,16,16,26,15,39,25,26,175</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" lower_limit="75" upper_limit="99"/>
                    <measurement group_id="O2" value="100" lower_limit="81" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="79" upper_limit="100"/>
                    <measurement group_id="O5" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O6" value="93" lower_limit="68" upper_limit="100"/>
                    <measurement group_id="O7" value="97" lower_limit="87" upper_limit="100"/>
                    <measurement group_id="O8" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O9" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O10" value="63" lower_limit="55" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain; N=26,18,16,15,25,15,38,25,26,168</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O2" value="94" lower_limit="73" upper_limit="100"/>
                    <measurement group_id="O3" value="94" lower_limit="70" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="78" upper_limit="100"/>
                    <measurement group_id="O5" value="92" lower_limit="74" upper_limit="99"/>
                    <measurement group_id="O6" value="100" lower_limit="78" upper_limit="100"/>
                    <measurement group_id="O7" value="97" lower_limit="86" upper_limit="100"/>
                    <measurement group_id="O8" value="96" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="O9" value="85" lower_limit="65" upper_limit="96"/>
                    <measurement group_id="O10" value="86" lower_limit="80" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,173</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81" lower_limit="61" upper_limit="93"/>
                    <measurement group_id="O2" value="61" lower_limit="36" upper_limit="83"/>
                    <measurement group_id="O3" value="81" lower_limit="54" upper_limit="96"/>
                    <measurement group_id="O4" value="69" lower_limit="41" upper_limit="89"/>
                    <measurement group_id="O5" value="88" lower_limit="70" upper_limit="98"/>
                    <measurement group_id="O6" value="73" lower_limit="45" upper_limit="92"/>
                    <measurement group_id="O7" value="88" lower_limit="73" upper_limit="96"/>
                    <measurement group_id="O8" value="72" lower_limit="51" upper_limit="88"/>
                    <measurement group_id="O9" value="85" lower_limit="65" upper_limit="96"/>
                    <measurement group_id="O10" value="17" lower_limit="12" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=24,17,16,12,23,15,35,24,25,158</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" lower_limit="19" upper_limit="59"/>
                    <measurement group_id="O2" value="47" lower_limit="23" upper_limit="72"/>
                    <measurement group_id="O3" value="31" lower_limit="11" upper_limit="59"/>
                    <measurement group_id="O4" value="33" lower_limit="10" upper_limit="65"/>
                    <measurement group_id="O5" value="39" lower_limit="20" upper_limit="61"/>
                    <measurement group_id="O6" value="40" lower_limit="16" upper_limit="68"/>
                    <measurement group_id="O7" value="49" lower_limit="31" upper_limit="66"/>
                    <measurement group_id="O8" value="46" lower_limit="26" upper_limit="67"/>
                    <measurement group_id="O9" value="32" lower_limit="15" upper_limit="54"/>
                    <measurement group_id="O10" value="21" lower_limit="15" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules</title>
        <description>The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.</description>
        <time_frame>Day 31 (1 month post vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B12 14_48</title>
            <description>Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B18 20_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B24 26_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B48_50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules</title>
          <description>The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA≥ 1:5 (H44/76 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="69" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="74" upper_limit="100"/>
                    <measurement group_id="O4" value="71" lower_limit="64" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:5 (5/99 strain; N=95,10,12,171)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="69" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="74" upper_limit="100"/>
                    <measurement group_id="O4" value="90" lower_limit="85" upper_limit="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:5 (NZ 98/254 strain; N=95,10,12,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96" lower_limit="90" upper_limit="99"/>
                    <measurement group_id="O2" value="70" lower_limit="35" upper_limit="93"/>
                    <measurement group_id="O3" value="100" lower_limit="74" upper_limit="100"/>
                    <measurement group_id="O4" value="24" lower_limit="18" upper_limit="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:5 (M10713 strain; N=90,9,10,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" lower_limit="86" upper_limit="98"/>
                    <measurement group_id="O2" value="100" lower_limit="66" upper_limit="100"/>
                    <measurement group_id="O3" value="90" lower_limit="55" upper_limit="100"/>
                    <measurement group_id="O4" value="77" lower_limit="70" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (H44/76 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="69" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="74" upper_limit="100"/>
                    <measurement group_id="O4" value="63" lower_limit="55" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (5/99 strain; N=94,10,12,171)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="69" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="74" upper_limit="100"/>
                    <measurement group_id="O4" value="87" lower_limit="81" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (NZ 98/254 strain; N=95,10,12,173)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95" lower_limit="88" upper_limit="98"/>
                    <measurement group_id="O2" value="60" lower_limit="26" upper_limit="88"/>
                    <measurement group_id="O3" value="100" lower_limit="74" upper_limit="100"/>
                    <measurement group_id="O4" value="17" lower_limit="12" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (M10713 strain; N=90,9,10,167)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" lower_limit="85" upper_limit="97"/>
                    <measurement group_id="O2" value="100" lower_limit="66" upper_limit="100"/>
                    <measurement group_id="O3" value="90" lower_limit="55" upper_limit="100"/>
                    <measurement group_id="O4" value="74" lower_limit="67" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules</title>
        <description>The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.</description>
        <time_frame>Day 31 (1 month post vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B12 14_48</title>
            <description>Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B18 20_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B24 26_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules</title>
          <description>The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154" lower_limit="124" upper_limit="191"/>
                    <measurement group_id="O2" value="145" lower_limit="76" upper_limit="277"/>
                    <measurement group_id="O3" value="211" lower_limit="116" upper_limit="383"/>
                    <measurement group_id="O4" value="11" lower_limit="8.51" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain; N= 94,10,12,171</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1575" lower_limit="1219" upper_limit="2034"/>
                    <measurement group_id="O2" value="2381" lower_limit="1112" upper_limit="5095"/>
                    <measurement group_id="O3" value="3604" lower_limit="1785" upper_limit="7278"/>
                    <measurement group_id="O4" value="34" lower_limit="27" upper_limit="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=95,10,12,173</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="25" upper_limit="39"/>
                    <measurement group_id="O2" value="18" lower_limit="8.87" upper_limit="35"/>
                    <measurement group_id="O3" value="47" lower_limit="25" upper_limit="88"/>
                    <measurement group_id="O4" value="2.25" lower_limit="1.84" upper_limit="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=90,9,10,167</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" lower_limit="29" upper_limit="49"/>
                    <measurement group_id="O2" value="74" lower_limit="34" upper_limit="164"/>
                    <measurement group_id="O3" value="84" lower_limit="39" upper_limit="180"/>
                    <measurement group_id="O4" value="20" lower_limit="15" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.</title>
        <description>The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.</description>
        <time_frame>Day 31 (1 month post vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B12 14_48</title>
            <description>Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B18 20_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B24 26_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.</title>
          <description>The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="79" upper_limit="125"/>
                    <measurement group_id="O2" value="67" lower_limit="34" upper_limit="135"/>
                    <measurement group_id="O3" value="133" lower_limit="68" upper_limit="258"/>
                    <measurement group_id="O4" value="10" lower_limit="8.2" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain; N=92,10,11,168</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" lower_limit="57" upper_limit="86"/>
                    <measurement group_id="O2" value="51" lower_limit="27" upper_limit="95"/>
                    <measurement group_id="O3" value="55" lower_limit="30" upper_limit="99"/>
                    <measurement group_id="O4" value="29" lower_limit="23" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=93,10,11,173</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" lower_limit="21" upper_limit="36"/>
                    <measurement group_id="O2" value="5.96" lower_limit="2.7" upper_limit="13"/>
                    <measurement group_id="O3" value="38" lower_limit="18" upper_limit="81"/>
                    <measurement group_id="O4" value="2.25" lower_limit="1.84" upper_limit="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=88,9,9,158</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.24" lower_limit="3.91" upper_limit="7.02"/>
                    <measurement group_id="O2" value="7.06" lower_limit="2.92" upper_limit="17"/>
                    <measurement group_id="O3" value="7.35" lower_limit="3.03" upper_limit="18"/>
                    <measurement group_id="O4" value="2" lower_limit="1.62" upper_limit="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine</title>
        <description>The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.&#xD;
Fourfold increase is defined as- for subjects with a pre-vaccination titer &lt;1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.</description>
        <time_frame>Day 31 (1 month post vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B12 14_48</title>
            <description>Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B18 20_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B24 26_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine</title>
          <description>The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.&#xD;
Fourfold increase is defined as- for subjects with a pre-vaccination titer &lt;1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O2" value="90" lower_limit="55" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="72" upper_limit="100"/>
                    <measurement group_id="O4" value="63" lower_limit="55" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain; N=92,10,11,168</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="90" lower_limit="55" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="72" upper_limit="100"/>
                    <measurement group_id="O4" value="86" lower_limit="80" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=93,10,11,173</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="86" upper_limit="98"/>
                    <measurement group_id="O2" value="50" lower_limit="19" upper_limit="81"/>
                    <measurement group_id="O3" value="100" lower_limit="72" upper_limit="100"/>
                    <measurement group_id="O4" value="17" lower_limit="12" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=88,9,9,158</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" lower_limit="47" upper_limit="68"/>
                    <measurement group_id="O2" value="67" lower_limit="30" upper_limit="93"/>
                    <measurement group_id="O3" value="56" lower_limit="21" upper_limit="86"/>
                    <measurement group_id="O4" value="21" lower_limit="15" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.</title>
        <description>The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.&#xD;
Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.&#xD;
Immune sufficiency was not applicable for M10713 strain.</description>
        <time_frame>Day 91 (1 month post second vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B48_50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.</title>
          <description>The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.&#xD;
Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.&#xD;
Immune sufficiency was not applicable for M10713 strain.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA≥ 1:5 (H44/76 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:5 (5/99 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:5 (NZ 98/254 strain; N=174)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91" lower_limit="85" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (H44/76 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (5/99 strain)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA≥ 1:8 (NZ 98/254 strain; N=174)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="73" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</title>
        <description>The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.</description>
        <time_frame>Day 91 (1 month post second vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</title>
          <description>The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109" lower_limit="98" upper_limit="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343" lower_limit="302" upper_limit="389"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=174</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="14" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=171</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" lower_limit="40" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</title>
        <description>The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.</description>
        <time_frame>Day 91 (1 month post second vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</title>
          <description>The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" lower_limit="94" upper_limit="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain; N=172</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299" lower_limit="256" upper_limit="350"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=174</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="14" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=171</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.12" lower_limit="3.95" upper_limit="6.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</title>
        <description>The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.</description>
        <time_frame>Day 91 (1 month post second vaccination)</time_frame>
        <population>Analysis was done on FAS (Immunogenicity).</population>
        <group_list>
          <group group_id="O1">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</title>
          <description>The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.</description>
          <population>Analysis was done on FAS (Immunogenicity).</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H44/76 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5/99 strain; N=172</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NZ 98/254 strain; N=174</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="73" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M10713 strain; N=161</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" lower_limit="43" upper_limit="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</title>
        <description>The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.</description>
        <time_frame>From day 1 to day 7 after vaccination</time_frame>
        <population>Analysis was done on the safety population, ie, all subjects in the Exposed population who provided post vaccination and post-baseline safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>B+R246_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B+R246_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B+R246_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B246_12_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O5">
            <title>B246_18_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O6">
            <title>B246_24_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O7">
            <title>B+R234_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O8">
            <title>B+R234_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O9">
            <title>B+R234_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</title>
          <description>The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.</description>
          <population>Analysis was done on the safety population, ie, all subjects in the Exposed population who provided post vaccination and post-baseline safety data.</population>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="27"/>
                <count group_id="O6" value="17"/>
                <count group_id="O7" value="43"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any local</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="24"/>
                    <measurement group_id="O6" value="17"/>
                    <measurement group_id="O7" value="38"/>
                    <measurement group_id="O8" value="28"/>
                    <measurement group_id="O9" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (mild)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="6"/>
                    <measurement group_id="O9" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (moderate)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="9"/>
                    <measurement group_id="O7" value="24"/>
                    <measurement group_id="O8" value="14"/>
                    <measurement group_id="O9" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (severe)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="8"/>
                    <measurement group_id="O9" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (25 - 50 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="6"/>
                    <measurement group_id="O9" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (51 - 100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="6"/>
                    <measurement group_id="O9" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (&gt;100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (25 - 50 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="7"/>
                    <measurement group_id="O9" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (51 - 100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (&gt;100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (25 - 50 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="7"/>
                    <measurement group_id="O9" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (51 - 100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (&gt;100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="19"/>
                    <measurement group_id="O6" value="13"/>
                    <measurement group_id="O7" value="36"/>
                    <measurement group_id="O8" value="27"/>
                    <measurement group_id="O9" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in eating habits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="20"/>
                    <measurement group_id="O8" value="11"/>
                    <measurement group_id="O9" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralagia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="8"/>
                    <measurement group_id="O9" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="23"/>
                    <measurement group_id="O8" value="20"/>
                    <measurement group_id="O9" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥ 38.0 °C)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antipyretic used (prophylactically)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antipyretic used (therapeutically)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</title>
        <description>The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.</description>
        <time_frame>From day 1 to day 7 after vaccination</time_frame>
        <population>Analysis was done on the safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>B12 14_48</title>
            <description>Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B18 20_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B24 26_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</title>
          <description>The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.</description>
          <population>Analysis was done on the safety population.</population>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any local</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (mild)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (moderate)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (severe)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (25 - 50 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (51 - 100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (&gt;100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (25 - 50 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (51 - 100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (&gt;100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (25 - 50 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (51 - 100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (&gt;100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in eating habits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralagia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥ 38.0 °C)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antipyretic used (prophylactically)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antipyretic used (therapeutically)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</title>
        <description>The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.</description>
        <time_frame>From day 1 to day 7 after any vaccination</time_frame>
        <population>Analysis was done on the safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>B48 50 (After 1st Dose)</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
          <group group_id="O2">
            <title>B48 50 (After 2nd Dose)</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age</title>
          <description>The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.</description>
          <population>Analysis was done on the safety population.</population>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="205"/>
                <count group_id="O2" value="194"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any local</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="186"/>
                    <measurement group_id="O2" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (mild)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (moderate)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (severe)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (25 - 50 mm; N= 204, 194)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (51 - 100 mm; N= 204, 194)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (&gt;100 mm; N= 204, 194)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (25 - 50 mm; N= 204, 194</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (51-100 mm; N= 204, 194)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration(&gt;100 mm; N= 204, 194</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (25 - 50 mm; N= 204, 194</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (51 - 100 mm; N= 204, 194)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (&gt;100 mm; N= 204, 194)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137"/>
                    <measurement group_id="O2" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash; N=201, 192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in eating habits; N= 203, 194</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache; N= 204, 194</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralagia; N= 203, 192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability; N= 204, 193</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea; N= 204, 193</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥ 38.0 °C; N= 204, 189)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antipyretic used (prophylactically; N= 204, 193)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Antipyretic used (therapeutically; N= 204, 193)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</title>
        <description>The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.</description>
        <time_frame>From day 1 to study termination</time_frame>
        <population>Analysis was done on the safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>B+R246_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B+R246_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B+R246_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O4">
            <title>B246_12_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O5">
            <title>B246_18_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O6">
            <title>B246_24_48</title>
            <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O7">
            <title>B+R234_12_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O8">
            <title>B+R234_18_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O9">
            <title>B+R234_24_48</title>
            <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</title>
          <description>The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.</description>
          <population>Analysis was done on the safety population.</population>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="19"/>
                <count group_id="O5" value="27"/>
                <count group_id="O6" value="17"/>
                <count group_id="O7" value="43"/>
                <count group_id="O8" value="29"/>
                <count group_id="O9" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="11"/>
                    <measurement group_id="O9" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</title>
        <description>The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.</description>
        <time_frame>From day 1 to study termination</time_frame>
        <population>Analysis was done on the safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>B12 14_48</title>
            <description>Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O2">
            <title>B18 20_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
          <group group_id="O3">
            <title>B24 26_48</title>
            <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)</title>
          <description>The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.</description>
          <population>Analysis was done on the safety population.</population>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Unsolicited AEs After Any Vaccination.</title>
        <description>The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.</description>
        <time_frame>From day 1 to study termination</time_frame>
        <population>Analysis was done on the safety population.</population>
        <group_list>
          <group group_id="O1">
            <title>B48 50</title>
            <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Unsolicited AEs After Any Vaccination.</title>
          <description>The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.</description>
          <population>Analysis was done on the safety population.</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to premature withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.</time_frame>
      <desc>Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assessment. Number of participants at risk in groups, B+R246_12_48, B+R246_18_48, B+R246_24_48, B246_12_48, B246_18_48, B246_24_48 si referred to the subsect of subjects who actually received vaccination in the present study.</desc>
      <group_list>
        <group group_id="E1">
          <title>B+R246_12_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E2">
          <title>B+R246_18_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E3">
          <title>B+R246_24_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E4">
          <title>B246_12_48</title>
          <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E5">
          <title>B246_18_48</title>
          <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E6">
          <title>B246_24_48</title>
          <description>Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E7">
          <title>B+R234_12_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E8">
          <title>B+R234_18_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E9">
          <title>B+R234_24_48</title>
          <description>Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E10">
          <title>B12 14_48</title>
          <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &amp;14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E11">
          <title>B18 20_48</title>
          <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 &amp; 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E12">
          <title>B24 26_48</title>
          <description>Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 &amp; 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.</description>
        </group>
        <group group_id="E13">
          <title>B48 50</title>
          <description>Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CROUP INFECTIOUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>CONCUSSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>CONTUSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>PERIORBITAL HAEMATOMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="25" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="17" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="42" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="28" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="27" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="97" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="10" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="12" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="200" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>INJECTION SITE ERYTHEMA</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="21" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="38" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="24" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="23" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="73" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="8" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="7" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="166" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>INJECTION SITE INDURATION</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="24" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="21" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="19" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="46" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="117" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>INJECTION SITE PAIN</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="23" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="38" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="28" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="27" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="94" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="9" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="11" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="192" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>INJECTION SITE SWELLING</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="25" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="17" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="14" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="46" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="7" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="96" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="19" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="36" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ACUTE TONSILLITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>EAR INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="6" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>ERYTHEMA INFECTIOSUM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>VIRAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="11" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="12" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="28" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="67" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>SOMNOLENCE</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="22" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="21" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="14" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="52" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="105" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="20" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="40" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>EATING DISORDER</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="20" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="13" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="42" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="75" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>IRRITABILITY</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="23" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="20" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="16" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="53" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="91" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="11" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>RHINORRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>CATARRH</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ERYTHEMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="206"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="43"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E10" subjects_affected="13" subjects_at_risk="100"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E13" subjects_affected="24" subjects_at_risk="206"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Posting Director</name_or_title>
      <organization>Novartis Vaccines and Diagnostics</organization>
      <email>RegistryContactVaccinesUS@novartis.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717638
org study id: V72P12E2
secondary id: 2011-004931-30
nct id: NCT01717638
lead sponsor: 
has dmc: No
It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second
      extension study is to explore the bactericidal antibody persistence in 4-year-old children
      after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV
      NZ administered to toddlers as part of their respective vaccination courses in study
      V72P12E1.

      In addition, this study will characterize the antibody response to a fifth dose boost in all
      children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age
      (in parent study V72P12, NCT00721396), and only in a subset of children who received a
      three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12).
      Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ
      administered at approximately 4 years of age in all children who received a two catch-up
      doses of rMenB+OMV NZ as toddlers in study V72P12E1.

      Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2
      months apart to healthy naïve children at 4 years of age will be assessed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
time frame: Day 1 (24-36 months post booster; baseline for naive)
description: The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.
The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
measure: Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
time frame: Day 1 (24-36 months post booster; baseline for naive)
description: The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).
measure: Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules
time frame: Day 1 (24-36 months post booster dose; baseline for naive)
description: The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.
measure: Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
time frame: Day 1 (22-34 months post last MenB vaccine)
description: The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.
measure: Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
time frame: Day 1 (22-36 months post last MenB vaccine; baseline for naive)
description: The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.
measure: GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules
time frame: Day 1 (22-34 months post last MenB vaccine)
description: The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.
measure: Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
time frame: Day 31 (1 month post vaccination)
description: The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.
measure: GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
time frame: Day 31 (1 month post vaccination)
description: The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.
measure: Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
time frame: Day 31 (1 month post vaccination)
description: The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.
measure: Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules
time frame: Day 31 (1 month post vaccination)
description: The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.
measure: Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
time frame: Day 31 (1 month post vaccination)
description: The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
measure: GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules
time frame: Day 31 (1 month post vaccination)
description: The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.
measure: GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.
time frame: Day 31 (1 month post vaccination)
description: The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.
measure: Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine
time frame: Day 31 (1 month post vaccination)
description: The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.
Fourfold increase is defined as- for subjects with a pre-vaccination titer <1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.
measure: Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.
time frame: Day 91 (1 month post second vaccination)
description: The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.
Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.
Immune sufficiency was not applicable for M10713 strain.
measure: GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
time frame: Day 91 (1 month post second vaccination)
description: The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.
measure: GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
time frame: Day 91 (1 month post second vaccination)
description: The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.
measure: Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
time frame: Day 91 (1 month post second vaccination)
description: The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
time frame: From day 1 to day 7 after vaccination
description: The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
time frame: From day 1 to day 7 after vaccination
description: The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
time frame: From day 1 to day 7 after any vaccination
description: The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.
measure: Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
time frame: From day 1 to study termination
description: The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.
measure: Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
time frame: From day 1 to study termination
description: The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
measure: Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
time frame: From day 1 to study termination
description: The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.
arm group label: B+R246_12_48
arm group type: Experimental
description: Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B+R246_18_48
arm group type: Experimental
description: Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B+R246_24_48
arm group type: Experimental
description: Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B246_12_48
arm group type: Experimental
description: Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B246_18_48
arm group type: Experimental
description: Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B246_24_48
arm group type: Experimental
description: Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B+R234_12_48
arm group type: Experimental
description: Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B+R234_18_48
arm group type: Experimental
description: Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B+R234_24_48
arm group type: Experimental
description: Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B12 14_48
arm group type: Experimental
description: Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 12 and14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B18 20_48
arm group type: Experimental
description: Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B24 26_48
arm group type: Experimental
description: Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
arm group label: B48_50
arm group type: Experimental
description: Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine, two months apart, in the present study.
intervention type: Biological
intervention name: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
description: 0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
arm group label: B+R234_12_48
arm group label: B+R234_18_48
arm group label: B+R234_24_48
arm group label: B+R246_12_48
arm group label: B+R246_18_48
arm group label: B+R246_24_48
arm group label: B12 14_48
arm group label: B18 20_48
arm group label: B24 26_48
arm group label: B246_12_48
arm group label: B246_18_48
arm group label: B246_24_48
other name: rMenB+OMV NZ
intervention type: Biological
intervention name: 2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
description: 0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart
arm group label: B48_50
other name: rMenB+OMV NZ
criteria: 
gender: All
minimum age: 48 Months
maximum age: 60 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Novartis Vaccines
role: Study Chair
affiliation: Novartis Vaccines
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country: Czech Republic
country: Italy
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Meningococcal Infections
mesh term: Meningitis, Meningococcal
mesh term: Meningitis
mesh term: Vaccines
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certain agreements: 
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