<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/NCT02207816</url>
  </required_header>
  <id_info>
    <org_study_id>200599</org_study_id>
    <nct_id>NCT02207816</nct_id>
  </id_info>
  <brief_title>An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa</brief_title>
  <official_title>Extension to Study MALARIA-055 PRI (NCT00866619) for Evaluation of Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine (SB257049) in Infants and Children in Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to conduct long-term surveillance for efficacy, safety and&#xD;
      immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria&#xD;
      vaccine in infants and children in Africa following a primary vaccination series&#xD;
      (NCT00866619). No new subjects will be enrolled in this extension study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2014</start_date>
  <completion_date type="Actual">January 31, 2017</completion_date>
  <primary_completion_date type="Actual">January 31, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Severe Malaria Meeting Case Definition 1</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Severe Malaria Meeting Case Definition 2.</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Clinical Malaria Meeting Case Definition</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Prevalent Parasitemia</measure>
    <time_frame>At Years 1, 2 and 3</time_frame>
    <description>Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (&gt;) 0 parasites/µL, identified at an annual visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin &lt;5g/dL)</measure>
    <time_frame>At Years 1, 2 and 3</time_frame>
    <description>Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (&lt;) 5.0 grams per deciliter (g/dL), identified at an annual visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin &lt;8g/dL)</measure>
    <time_frame>At Years 1, 2 and 3</time_frame>
    <description>Prevalent moderate anemia (PMA) was defined as a documented hemoglobin &lt; 8.0 g/dL, identified at an annual visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Severe Malaria Meeting Case Definition 1.</measure>
    <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)</time_frame>
    <description>Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Severe Malaria Meeting Case Definition 2.</measure>
    <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)</time_frame>
    <description>Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Clinical Malaria Meeting Case Definition</measure>
    <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)</time_frame>
    <description>Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.</measure>
    <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)</time_frame>
    <description>Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.</measure>
    <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</time_frame>
    <description>Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Fatal Malaria Meeting Case Definition 1.</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Fatal Malaria Meeting Case Definition 2.</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Cerebral Malaria</measure>
    <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</time_frame>
    <description>Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Fatal Malaria Meeting Case Definition 1.</measure>
    <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</time_frame>
    <description>Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Fatal Malaria Meeting Case Definition 2.</measure>
    <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</time_frame>
    <description>Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as 'malaria', 'Plasmodium falciparum infection' or 'cerebral malaria&quot;. A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Meningitis SAEs</measure>
    <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
    <description>For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)</measure>
    <time_frame>At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)</time_frame>
    <description>Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3084</enrollment>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>GSK257049 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GSK257049 Comparator Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VeroRab/Menjugate Comparator Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.</description>
    <arm_group_label>GSK257049 Comparator Group</arm_group_label>
    <arm_group_label>GSK257049 Group</arm_group_label>
    <arm_group_label>VeroRab/Menjugate Comparator Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Malaria Vaccine 257049 (MALARIA-055 PRI)</intervention_name>
    <description>Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).</description>
    <arm_group_label>GSK257049 Comparator Group</arm_group_label>
    <arm_group_label>GSK257049 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)</intervention_name>
    <description>Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).</description>
    <arm_group_label>GSK257049 Comparator Group</arm_group_label>
    <arm_group_label>VeroRab/Menjugate Comparator Group</arm_group_label>
    <other_name>Menjugate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cell-culture rabies vaccine (MALARIA-055 PRI)</intervention_name>
    <description>Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).</description>
    <arm_group_label>VeroRab/Menjugate Comparator Group</arm_group_label>
    <other_name>VeroRab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TritanrixHepB/Hib (MALARIA-055 PRI)</intervention_name>
    <description>Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).</description>
    <arm_group_label>GSK257049 Comparator Group</arm_group_label>
    <arm_group_label>GSK257049 Group</arm_group_label>
    <arm_group_label>VeroRab/Menjugate Comparator Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)</intervention_name>
    <description>Administered orally, during the MALARIA-055 study (NCT00866619).</description>
    <arm_group_label>GSK257049 Comparator Group</arm_group_label>
    <arm_group_label>GSK257049 Group</arm_group_label>
    <arm_group_label>VeroRab/Menjugate Comparator Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects' parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of&#xD;
             the investigator, can and will comply with the requirements of the protocol.&#xD;
&#xD;
          -  Subjects who were enrolled and who received at least one vaccine dose in the primary&#xD;
             study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who&#xD;
             moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.&#xD;
&#xD;
          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child in care.&#xD;
&#xD;
          -  Use of any investigational or non-registered product or planned use during the study&#xD;
             period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Months</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ouagadougou</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tanga</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
    <country>Kenya</country>
    <country>Tanzania</country>
  </location_countries>
  <reference>
    <citation>Tinto H, Otieno W, Gesase S, Sorgho H, Otieno L, Liheluka E, Valea I, Sing'oei V, Malabeja A, Valia D, Wangwe A, Gvozdenovic E, Guerra Mendoza Y, Jongert E, Lievens M, Roman F, Schuerman L, Lusingu J. Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial. Lancet Infect Dis. 2019 Aug;19(8):821-832. doi: 10.1016/S1473-3099(19)30300-7. Epub 2019 Jul 9.</citation>
    <PMID>31300331</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>January 29, 2018</results_first_submitted>
  <results_first_submitted_qc>July 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 15, 2019</results_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infants</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Children</keyword>
  <keyword>Malaria</keyword>
  <keyword>Plasmodium falciparum</keyword>
  <keyword>Safety</keyword>
  <keyword>Surveillance</keyword>
  <keyword>Immunogenicity</keyword>
  <keyword>RTS,S/AS01E</keyword>
  <keyword>Africa</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com/Posting.aspx?ID=20045</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 15, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02207816/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 12, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02207816/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The randomization that was performed in the primary study NCT00866619 was kept for this extension, in which subjects from 3 sites were enrolled. Subjects remained in the same groups as the ones of the primary study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>GSK257049 Group</title>
          <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
        </group>
        <group group_id="P2">
          <title>GSK257049 Comparator Group</title>
          <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
        </group>
        <group group_id="P3">
          <title>VeroRab/Menjugate Comparator Group</title>
          <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this 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="1046"/>
                <participants group_id="P2" count="1010"/>
                <participants group_id="P3" count="1028"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="995"/>
                <participants group_id="P2" count="924"/>
                <participants group_id="P3" count="961"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="86"/>
                <participants group_id="P3" count="67"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Serious Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Eligibility Criteria Not Fulfilled</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Migrated/Moved From Study Area</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="60"/>
                <participants group_id="P3" count="51"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GSK257049 Group</title>
          <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
        </group>
        <group group_id="B2">
          <title>GSK257049 Comparator Group</title>
          <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
        </group>
        <group group_id="B3">
          <title>VeroRab/Menjugate Comparator Group</title>
          <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
        </group>
        <group group_id="B4">
          <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="1046"/>
            <count group_id="B2" value="1010"/>
            <count group_id="B3" value="1028"/>
            <count group_id="B4" value="3084"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.25" spread="0.99"/>
                    <measurement group_id="B2" value="5.23" spread="0.99"/>
                    <measurement group_id="B3" value="5.26" spread="0.97"/>
                    <measurement group_id="B4" value="5.25" spread="0.98"/>
                  </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="517"/>
                    <measurement group_id="B2" value="480"/>
                    <measurement group_id="B3" value="515"/>
                    <measurement group_id="B4" value="1512"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="529"/>
                    <measurement group_id="B2" value="530"/>
                    <measurement group_id="B3" value="513"/>
                    <measurement group_id="B4" value="1572"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African Heritage/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1046"/>
                    <measurement group_id="B2" value="1010"/>
                    <measurement group_id="B3" value="1028"/>
                    <measurement group_id="B4" value="3084"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Severe Malaria Meeting Case Definition 1</title>
        <description>Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding study vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Severe Malaria Meeting Case Definition 1</title>
          <description>Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding study vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>events per person-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="561"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="459"/>
                <count group_id="O5" value="456"/>
                <count group_id="O6" value="442"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.001"/>
                    <measurement group_id="O2" value="0.002"/>
                    <measurement group_id="O3" value="0.002"/>
                    <measurement group_id="O4" value="0.004"/>
                    <measurement group_id="O5" value="0.003"/>
                    <measurement group_id="O6" value="0.005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2235</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>74.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-130</ci_lower_limit>
            <ci_upper_limit>97.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8972</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-9.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-339</ci_lower_limit>
            <ci_upper_limit>72.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5333</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>30.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-119</ci_lower_limit>
            <ci_upper_limit>78.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3523</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>44.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-90.9</ci_lower_limit>
            <ci_upper_limit>83.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Severe Malaria Meeting Case Definition 2.</title>
        <description>Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Severe Malaria Meeting Case Definition 2.</title>
          <description>Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>events per person-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="561"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="459"/>
                <count group_id="O5" value="456"/>
                <count group_id="O6" value="442"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.004"/>
                    <measurement group_id="O2" value="0.007"/>
                    <measurement group_id="O3" value="0.009"/>
                    <measurement group_id="O4" value="0.007"/>
                    <measurement group_id="O5" value="0.007"/>
                    <measurement group_id="O6" value="0.011"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0930</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>53.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.7</ci_lower_limit>
            <ci_upper_limit>81.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5035</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>23.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-67.1</ci_lower_limit>
            <ci_upper_limit>64.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3504</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>32.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-53.1</ci_lower_limit>
            <ci_upper_limit>69.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2704</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>37.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.4</ci_lower_limit>
            <ci_upper_limit>73.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Clinical Malaria Meeting Case Definition</title>
        <description>Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Clinical Malaria Meeting Case Definition</title>
          <description>Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>events per person-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="561"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="459"/>
                <count group_id="O5" value="456"/>
                <count group_id="O6" value="442"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.079"/>
                    <measurement group_id="O2" value="1.108"/>
                    <measurement group_id="O3" value="1.016"/>
                    <measurement group_id="O4" value="1.632"/>
                    <measurement group_id="O5" value="1.563"/>
                    <measurement group_id="O6" value="1.686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4434</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-5.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.0</ci_lower_limit>
            <ci_upper_limit>7.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2634</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-8.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.9</ci_lower_limit>
            <ci_upper_limit>5.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9278</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.7</ci_lower_limit>
            <ci_upper_limit>13.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4189</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>5.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.12</ci_lower_limit>
            <ci_upper_limit>17.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.</title>
        <description>Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.</title>
          <description>Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="561"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="459"/>
                <count group_id="O5" value="456"/>
                <count group_id="O6" value="442"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1302</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>50.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.2</ci_lower_limit>
            <ci_upper_limit>82.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6897</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>16.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-96.9</ci_lower_limit>
            <ci_upper_limit>65.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5299</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>25.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-82.9</ci_lower_limit>
            <ci_upper_limit>70.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5307</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>25.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-84.1</ci_lower_limit>
            <ci_upper_limit>70.70</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.</title>
        <description>Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.</title>
          <description>Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="561"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="459"/>
                <count group_id="O5" value="456"/>
                <count group_id="O6" value="442"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1853</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>46.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-45.0</ci_lower_limit>
            <ci_upper_limit>81.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3828</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>35.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-69.3</ci_lower_limit>
            <ci_upper_limit>76.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4112</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>31.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-66.5</ci_lower_limit>
            <ci_upper_limit>72.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4121</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>30.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-67.6</ci_lower_limit>
            <ci_upper_limit>72.50</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Prevalent Parasitemia</title>
        <description>Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (&gt;) 0 parasites/µL, identified at an annual visit.</description>
        <time_frame>At Years 1, 2 and 3</time_frame>
        <population>The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Prevalent Parasitemia</title>
          <description>Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (&gt;) 0 parasites/µL, identified at an annual visit.</description>
          <population>The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="565"/>
                <count group_id="O2" value="525"/>
                <count group_id="O3" value="561"/>
                <count group_id="O4" value="436"/>
                <count group_id="O5" value="435"/>
                <count group_id="O6" value="420"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Prevalent parasitemia, Year 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="139"/>
                    <count group_id="O3" value="154"/>
                    <count group_id="O4" value="168"/>
                    <count group_id="O5" value="176"/>
                    <count group_id="O6" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="89"/>
                    <measurement group_id="O4" value="48"/>
                    <measurement group_id="O5" value="65"/>
                    <measurement group_id="O6" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevalent parasitemia, Year 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="565"/>
                    <count group_id="O2" value="525"/>
                    <count group_id="O3" value="561"/>
                    <count group_id="O4" value="436"/>
                    <count group_id="O5" value="435"/>
                    <count group_id="O6" value="420"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="156"/>
                    <measurement group_id="O4" value="116"/>
                    <measurement group_id="O5" value="133"/>
                    <measurement group_id="O6" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevalent parasitemia, Year 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="561"/>
                    <count group_id="O2" value="515"/>
                    <count group_id="O3" value="549"/>
                    <count group_id="O4" value="434"/>
                    <count group_id="O5" value="408"/>
                    <count group_id="O6" value="411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="148"/>
                    <measurement group_id="O3" value="158"/>
                    <measurement group_id="O4" value="106"/>
                    <measurement group_id="O5" value="105"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>40.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.70</ci_lower_limit>
            <ci_upper_limit>58.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine effiicacy</param_type>
            <param_value>42.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.40</ci_lower_limit>
            <ci_upper_limit>60.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0883</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>16.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.60</ci_lower_limit>
            <ci_upper_limit>33.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1889</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>13.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.7</ci_lower_limit>
            <ci_upper_limit>31.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0770</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>16.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.90</ci_lower_limit>
            <ci_upper_limit>34.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.8</ci_lower_limit>
            <ci_upper_limit>20.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1624</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>20.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.5</ci_lower_limit>
            <ci_upper_limit>46.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9112</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-2.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.6</ci_lower_limit>
            <ci_upper_limit>29.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4023</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>9.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.0</ci_lower_limit>
            <ci_upper_limit>30.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7091</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-4.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.5</ci_lower_limit>
            <ci_upper_limit>18.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9361</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-1.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.7</ci_lower_limit>
            <ci_upper_limit>23.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6280</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-6.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-42.0</ci_lower_limit>
            <ci_upper_limit>19.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin &lt;5g/dL)</title>
        <description>Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (&lt;) 5.0 grams per deciliter (g/dL), identified at an annual visit.</description>
        <time_frame>At Years 1, 2 and 3</time_frame>
        <population>The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin &lt;5g/dL)</title>
          <description>Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (&lt;) 5.0 grams per deciliter (g/dL), identified at an annual visit.</description>
          <population>The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="565"/>
                <count group_id="O2" value="528"/>
                <count group_id="O3" value="562"/>
                <count group_id="O4" value="437"/>
                <count group_id="O5" value="436"/>
                <count group_id="O6" value="421"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Prevalent severe anemia, Year 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="139"/>
                    <count group_id="O3" value="154"/>
                    <count group_id="O4" value="168"/>
                    <count group_id="O5" value="176"/>
                    <count group_id="O6" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevalent severe anemia, Year 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="565"/>
                    <count group_id="O2" value="528"/>
                    <count group_id="O3" value="562"/>
                    <count group_id="O4" value="437"/>
                    <count group_id="O5" value="436"/>
                    <count group_id="O6" value="421"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevalent severe anemia, Year 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="561"/>
                    <count group_id="O2" value="516"/>
                    <count group_id="O3" value="550"/>
                    <count group_id="O4" value="434"/>
                    <count group_id="O5" value="408"/>
                    <count group_id="O6" value="411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4987</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>100.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3779</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>100.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4051</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin &lt;8g/dL)</title>
        <description>Prevalent moderate anemia (PMA) was defined as a documented hemoglobin &lt; 8.0 g/dL, identified at an annual visit.</description>
        <time_frame>At Years 1, 2 and 3</time_frame>
        <population>The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin &lt;8g/dL)</title>
          <description>Prevalent moderate anemia (PMA) was defined as a documented hemoglobin &lt; 8.0 g/dL, identified at an annual visit.</description>
          <population>The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="565"/>
                <count group_id="O2" value="528"/>
                <count group_id="O3" value="562"/>
                <count group_id="O4" value="437"/>
                <count group_id="O5" value="436"/>
                <count group_id="O6" value="421"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Prevalent moderate anemia, Year 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="139"/>
                    <count group_id="O3" value="154"/>
                    <count group_id="O4" value="168"/>
                    <count group_id="O5" value="176"/>
                    <count group_id="O6" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevalent moderate anemia, Year 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="565"/>
                    <count group_id="O2" value="528"/>
                    <count group_id="O3" value="562"/>
                    <count group_id="O4" value="437"/>
                    <count group_id="O5" value="436"/>
                    <count group_id="O6" value="421"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevalent moderate anemia, Year 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="561"/>
                    <count group_id="O2" value="516"/>
                    <count group_id="O3" value="550"/>
                    <count group_id="O4" value="434"/>
                    <count group_id="O5" value="408"/>
                    <count group_id="O6" value="411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1025</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-254.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3399</ci_lower_limit>
            <ci_upper_limit>32.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0284</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-398.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4642</ci_lower_limit>
            <ci_upper_limit>-3.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3543</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>36.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-78.8</ci_lower_limit>
            <ci_upper_limit>79.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>3.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-151</ci_lower_limit>
            <ci_upper_limit>63.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3809</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>44.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-120</ci_lower_limit>
            <ci_upper_limit>88.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5490</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>39.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-140</ci_lower_limit>
            <ci_upper_limit>86.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3239</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-46.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-249</ci_lower_limit>
            <ci_upper_limit>36.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2184</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>47.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-54.5</ci_lower_limit>
            <ci_upper_limit>84.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0724</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-116.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-476</ci_lower_limit>
            <ci_upper_limit>10.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2055</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-81.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-393</ci_lower_limit>
            <ci_upper_limit>27.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8138</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-18.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-245</ci_lower_limit>
            <ci_upper_limit>57.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7887</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>24.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-148</ci_lower_limit>
            <ci_upper_limit>78.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Severe Malaria Meeting Case Definition 1.</title>
        <description>Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
        <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Severe Malaria Meeting Case Definition 1.</title>
          <description>Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
          <units>events per person-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="844"/>
                <count group_id="O2" value="829"/>
                <count group_id="O3" value="839"/>
                <count group_id="O4" value="637"/>
                <count group_id="O5" value="635"/>
                <count group_id="O6" value="633"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.009"/>
                    <measurement group_id="O2" value="0.016"/>
                    <measurement group_id="O3" value="0.015"/>
                    <measurement group_id="O4" value="0.014"/>
                    <measurement group_id="O5" value="0.013"/>
                    <measurement group_id="O6" value="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0077</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>40.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.84</ci_lower_limit>
            <ci_upper_limit>59.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7922</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-4.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-45.3</ci_lower_limit>
            <ci_upper_limit>24.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0802</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>29.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.22</ci_lower_limit>
            <ci_upper_limit>51.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0387</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>33.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.13</ci_lower_limit>
            <ci_upper_limit>55.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Severe Malaria Meeting Case Definition 2.</title>
        <description>Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
        <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Severe Malaria Meeting Case Definition 2.</title>
          <description>Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (&lt;) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia &lt; 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
          <units>events per person-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="844"/>
                <count group_id="O2" value="829"/>
                <count group_id="O3" value="839"/>
                <count group_id="O4" value="637"/>
                <count group_id="O5" value="635"/>
                <count group_id="O6" value="633"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.015"/>
                    <measurement group_id="O2" value="0.021"/>
                    <measurement group_id="O3" value="0.023"/>
                    <measurement group_id="O4" value="0.019"/>
                    <measurement group_id="O5" value="0.019"/>
                    <measurement group_id="O6" value="0.028"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0028</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>36.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.60</ci_lower_limit>
            <ci_upper_limit>53.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4430</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>10.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.1</ci_lower_limit>
            <ci_upper_limit>31.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0245</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>30.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.67</ci_lower_limit>
            <ci_upper_limit>50.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0122</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model without random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>34.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.74</ci_lower_limit>
            <ci_upper_limit>52.61</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Clinical Malaria Meeting Case Definition</title>
        <description>Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.</description>
        <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Clinical Malaria Meeting Case Definition</title>
          <description>Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
          <units>events per subject-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="844"/>
                <count group_id="O2" value="829"/>
                <count group_id="O3" value="839"/>
                <count group_id="O4" value="637"/>
                <count group_id="O5" value="635"/>
                <count group_id="O6" value="633"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.277"/>
                    <measurement group_id="O2" value="1.348"/>
                    <measurement group_id="O3" value="1.555"/>
                    <measurement group_id="O4" value="1.662"/>
                    <measurement group_id="O5" value="1.723"/>
                    <measurement group_id="O6" value="1.921"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>23.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.93</ci_lower_limit>
            <ci_upper_limit>30.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>19.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.81</ci_lower_limit>
            <ci_upper_limit>26.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0009</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>15.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.72</ci_lower_limit>
            <ci_upper_limit>23.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0056</p_value>
            <method>Negative binomial regression</method>
            <method_desc>Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].</method_desc>
            <param_type>Vaccine efficacy</param_type>
            <param_value>13.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.05</ci_lower_limit>
            <ci_upper_limit>21.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.</title>
        <description>Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
        <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.</title>
          <description>Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="844"/>
                <count group_id="O2" value="829"/>
                <count group_id="O3" value="839"/>
                <count group_id="O4" value="637"/>
                <count group_id="O5" value="635"/>
                <count group_id="O6" value="633"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="82"/>
                    <measurement group_id="O3" value="94"/>
                    <measurement group_id="O4" value="52"/>
                    <measurement group_id="O5" value="60"/>
                    <measurement group_id="O6" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0053</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>35.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.00</ci_lower_limit>
            <ci_upper_limit>54.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4255</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>11.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.0</ci_lower_limit>
            <ci_upper_limit>35.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0479</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>29.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.40</ci_lower_limit>
            <ci_upper_limit>51.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2346</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>18.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.9</ci_lower_limit>
            <ci_upper_limit>42.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.</title>
        <description>Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.</description>
        <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.</title>
          <description>Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="844"/>
                <count group_id="O2" value="829"/>
                <count group_id="O3" value="839"/>
                <count group_id="O4" value="637"/>
                <count group_id="O5" value="635"/>
                <count group_id="O6" value="633"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="79"/>
                    <measurement group_id="O3" value="93"/>
                    <measurement group_id="O4" value="54"/>
                    <measurement group_id="O5" value="60"/>
                    <measurement group_id="O6" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0051</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>35.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.30</ci_lower_limit>
            <ci_upper_limit>54.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3340</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>14.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.3</ci_lower_limit>
            <ci_upper_limit>37.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Meenjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0511</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>28.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.90</ci_lower_limit>
            <ci_upper_limit>50.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Meenjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1729</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>20.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.5</ci_lower_limit>
            <ci_upper_limit>44.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.</title>
        <description>Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.</title>
          <description>Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="561"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="459"/>
                <count group_id="O5" value="456"/>
                <count group_id="O6" value="442"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Fatal Malaria Meeting Case Definition 1.</title>
        <description>Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Fatal Malaria Meeting Case Definition 1.</title>
          <description>Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="561"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="459"/>
                <count group_id="O5" value="456"/>
                <count group_id="O6" value="442"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Fatal Malaria Meeting Case Definition 2.</title>
        <description>Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Fatal Malaria Meeting Case Definition 2.</title>
          <description>Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="561"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="459"/>
                <count group_id="O5" value="456"/>
                <count group_id="O6" value="442"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6244</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>50.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-859</ci_lower_limit>
            <ci_upper_limit>99.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-5.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1358</ci_lower_limit>
            <ci_upper_limit>92.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6244</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-188.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15000</ci_lower_limit>
            <ci_upper_limit>76.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>3.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7509</ci_lower_limit>
            <ci_upper_limit>98.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Cerebral Malaria</title>
        <description>Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.</description>
        <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Cerebral Malaria</title>
          <description>Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="844"/>
                <count group_id="O2" value="829"/>
                <count group_id="O3" value="839"/>
                <count group_id="O4" value="637"/>
                <count group_id="O5" value="635"/>
                <count group_id="O6" value="633"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6869</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-98.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2098</ci_lower_limit>
            <ci_upper_limit>71.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0213</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-406.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4650</ci_lower_limit>
            <ci_upper_limit>-7.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Fatal Malaria Meeting Case Definition 1.</title>
        <description>Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
        <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Fatal Malaria Meeting Case Definition 1.</title>
          <description>Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="844"/>
                <count group_id="O2" value="829"/>
                <count group_id="O3" value="839"/>
                <count group_id="O4" value="637"/>
                <count group_id="O5" value="635"/>
                <count group_id="O6" value="633"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-98.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12000</ci_lower_limit>
            <ci_upper_limit>89.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2154</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-304.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20000</ci_lower_limit>
            <ci_upper_limit>59.90</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Fatal Malaria Meeting Case Definition 2.</title>
        <description>Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.</description>
        <time_frame>From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Fatal Malaria Meeting Case Definition 2.</title>
          <description>Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="844"/>
                <count group_id="O2" value="829"/>
                <count group_id="O3" value="839"/>
                <count group_id="O4" value="637"/>
                <count group_id="O5" value="635"/>
                <count group_id="O6" value="633"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-24.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-526</ci_lower_limit>
            <ci_upper_limit>73.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3834</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-77.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-725</ci_lower_limit>
            <ci_upper_limit>55.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3740</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-297.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19000</ci_lower_limit>
            <ci_upper_limit>60.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1240</p_value>
            <method>Two-sided Fisher Exact test</method>
            <param_type>Vaccine efficacy</param_type>
            <param_value>-498.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27000</ci_lower_limit>
            <ci_upper_limit>27.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)</title>
        <description>Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as 'malaria', 'Plasmodium falciparum infection' or 'cerebral malaria&quot;. A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization.</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)</title>
          <description>Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as 'malaria', 'Plasmodium falciparum infection' or 'cerebral malaria&quot;. A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="560"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="457"/>
                <count group_id="O5" value="455"/>
                <count group_id="O6" value="440"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any SAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAE(s)</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaria SAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal SAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs</title>
        <description>Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules.</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs</title>
          <description>Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="560"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="457"/>
                <count group_id="O5" value="455"/>
                <count group_id="O6" value="440"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Meningitis SAEs</title>
        <description>For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'.</description>
        <time_frame>From Year 0 to Year 3 (Starting January 2014 and ending December 2016)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Meningitis SAEs</title>
          <description>For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="594"/>
                <count group_id="O2" value="560"/>
                <count group_id="O3" value="593"/>
                <count group_id="O4" value="457"/>
                <count group_id="O5" value="455"/>
                <count group_id="O6" value="440"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Meningitis meningococcal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meningitis</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="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meningitis bacterial</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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)</title>
        <description>Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points.</description>
        <time_frame>At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)</time_frame>
        <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK257049 [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O2">
            <title>GSK257049 Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O3">
            <title>VeroRab Comparator [5-17M] Group</title>
            <description>Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O4">
            <title>GSK257049 [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O5">
            <title>GSK257049 Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 20, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
          <group group_id="O6">
            <title>Menjugate Comparator [6-12W] Group</title>
            <description>Male or female infants between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12, in study NCT00866619 (Malaria-055). All vaccines were administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)</title>
          <description>Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points.</description>
          <population>The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.</population>
          <units>EU/mL</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="154"/>
                <count group_id="O2" value="152"/>
                <count group_id="O3" value="160"/>
                <count group_id="O4" value="141"/>
                <count group_id="O5" value="153"/>
                <count group_id="O6" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Month 3 of Malaria-055</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="152"/>
                    <count group_id="O3" value="160"/>
                    <count group_id="O4" value="141"/>
                    <count group_id="O5" value="153"/>
                    <count group_id="O6" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="671.8" lower_limit="601.1" upper_limit="750.7"/>
                    <measurement group_id="O2" value="599.3" lower_limit="534.0" upper_limit="672.5"/>
                    <measurement group_id="O3" value="0.3" lower_limit="0.2" upper_limit="0.3"/>
                    <measurement group_id="O4" value="152.9" lower_limit="121.4" upper_limit="192.4"/>
                    <measurement group_id="O5" value="169.0" lower_limit="135.9" upper_limit="210.0"/>
                    <measurement group_id="O6" value="0.3" lower_limit="0.2" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Month 20 of Malaria-055</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="146"/>
                    <count group_id="O3" value="145"/>
                    <count group_id="O4" value="134"/>
                    <count group_id="O5" value="144"/>
                    <count group_id="O6" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.0" lower_limit="31.1" upper_limit="46.5"/>
                    <measurement group_id="O2" value="40.3" lower_limit="33.8" upper_limit="48.2"/>
                    <measurement group_id="O3" value="0.3" lower_limit="0.3" upper_limit="0.3"/>
                    <measurement group_id="O4" value="4.2" lower_limit="3.2" upper_limit="5.6"/>
                    <measurement group_id="O5" value="5.5" lower_limit="4.2" upper_limit="7.2"/>
                    <measurement group_id="O6" value="0.3" lower_limit="0.3" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Month 21 of Malaria-055</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="146"/>
                    <count group_id="O3" value="146"/>
                    <count group_id="O4" value="131"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="368.6" lower_limit="329.1" upper_limit="412.9"/>
                    <measurement group_id="O2" value="38.8" lower_limit="32.5" upper_limit="46.2"/>
                    <measurement group_id="O3" value="0.3" lower_limit="0.3" upper_limit="0.3"/>
                    <measurement group_id="O4" value="149.3" lower_limit="119.4" upper_limit="186.6"/>
                    <measurement group_id="O5" value="5.3" lower_limit="4.0" upper_limit="6.9"/>
                    <measurement group_id="O6" value="0.3" lower_limit="0.3" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Month 32 of Malaria-055</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="145"/>
                    <count group_id="O4" value="125"/>
                    <count group_id="O5" value="142"/>
                    <count group_id="O6" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.7" lower_limit="47.3" upper_limit="63.3"/>
                    <measurement group_id="O2" value="21.1" lower_limit="17.6" upper_limit="25.2"/>
                    <measurement group_id="O3" value="0.3" lower_limit="0.3" upper_limit="0.3"/>
                    <measurement group_id="O4" value="11.7" lower_limit="8.6" upper_limit="16.0"/>
                    <measurement group_id="O5" value="3.6" lower_limit="2.9" upper_limit="4.6"/>
                    <measurement group_id="O6" value="0.4" lower_limit="0.3" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Year 1 of Malaria-076</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="45"/>
                    <count group_id="O5" value="56"/>
                    <count group_id="O6" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5" lower_limit="15.3" upper_limit="27.5"/>
                    <measurement group_id="O2" value="13.6" lower_limit="10.0" upper_limit="18.5"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.0" upper_limit="1.5"/>
                    <measurement group_id="O4" value="5.9" lower_limit="3.8" upper_limit="9.1"/>
                    <measurement group_id="O5" value="2.5" lower_limit="1.9" upper_limit="3.2"/>
                    <measurement group_id="O6" value="1.4" lower_limit="1.1" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Year 2 of Malaria-076</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="137"/>
                    <count group_id="O4" value="117"/>
                    <count group_id="O5" value="130"/>
                    <count group_id="O6" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" lower_limit="12.7" upper_limit="17.6"/>
                    <measurement group_id="O2" value="6.8" lower_limit="5.7" upper_limit="8.2"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O4" value="5.4" lower_limit="4.2" upper_limit="6.8"/>
                    <measurement group_id="O5" value="2.4" lower_limit="2.0" upper_limit="2.9"/>
                    <measurement group_id="O6" value="1.2" lower_limit="1.1" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Year 3 of Malaria-076</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="134"/>
                    <count group_id="O3" value="130"/>
                    <count group_id="O4" value="125"/>
                    <count group_id="O5" value="127"/>
                    <count group_id="O6" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" lower_limit="9.4" upper_limit="13.4"/>
                    <measurement group_id="O2" value="5.0" lower_limit="4.2" upper_limit="6.0"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.1" upper_limit="1.4"/>
                    <measurement group_id="O4" value="3.9" lower_limit="3.1" upper_limit="4.9"/>
                    <measurement group_id="O5" value="2.2" lower_limit="1.9" upper_limit="2.6"/>
                    <measurement group_id="O6" value="1.2" lower_limit="1.1" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious Adverse Events (SAEs): during the entire follow-up period, from Year 0 to Year 3 (Starting January 2014 and ending December 2016).</time_frame>
      <desc>Safety results include data for subjects who had a signed ICF for study Malaria-076 by the parent(s)/LAR(s), including SAE data from subjects who were not enrolled in study Malaria-076 but had a reason for non-participation (death) collected. Solicited and unsolicited AE(s) were not collected during this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>GSK257049 Group</title>
          <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
        </group>
        <group group_id="E2">
          <title>GSK257049 Comparator Group</title>
          <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
        </group>
        <group group_id="E3">
          <title>VeroRab/Menjugate Comparator Group</title>
          <description>Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1051"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="1015"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="1051"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="1015"/>
                <counts group_id="E3" subjects_affected="52" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1051"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1015"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Sickle cell anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Acute abdomen</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cholera</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Malaria</sub_title>
                <counts group_id="E1" events="38" subjects_affected="36" subjects_at_risk="1051"/>
                <counts group_id="E2" events="36" subjects_affected="36" subjects_at_risk="1015"/>
                <counts group_id="E3" events="56" subjects_affected="48" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Meningitis meningococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1051"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Typhoid fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Abdominal neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1051"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1015"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1033"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>cc781166@gsk.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/NCT02207816
org study id: 200599
nct id: NCT02207816
lead sponsor: 
The purpose of this study is to conduct long-term surveillance for efficacy, safety and
      immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria
      vaccine in infants and children in Africa following a primary vaccination series
      (NCT00866619). No new subjects will be enrolled in this extension study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of Severe Malaria Meeting Case Definition 1
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia < 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
measure: Incidence of Severe Malaria Meeting Case Definition 2.
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia < 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
measure: Incidence of Clinical Malaria Meeting Case Definition
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.
measure: Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).
measure: Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.
measure: Number of Subjects With Prevalent Parasitemia
time frame: At Years 1, 2 and 3
description: Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (>) 0 parasites/µL, identified at an annual visit.
measure: Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL)
time frame: At Years 1, 2 and 3
description: Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (<) 5.0 grams per deciliter (g/dL), identified at an annual visit.
measure: Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL)
time frame: At Years 1, 2 and 3
description: Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL, identified at an annual visit.
measure: Incidence of Severe Malaria Meeting Case Definition 1.
time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
description: Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia < 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
measure: Incidence of Severe Malaria Meeting Case Definition 2.
time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
description: Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia < 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
measure: Incidence of Clinical Malaria Meeting Case Definition
time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
description: Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.
measure: Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.
time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
description: Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).
measure: Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.
time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
description: Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.
measure: Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.
measure: Number of Subjects With Fatal Malaria Meeting Case Definition 1.
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).
measure: Number of Subjects With Fatal Malaria Meeting Case Definition 2.
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.
measure: Number of Subjects With Cerebral Malaria
time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
description: Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.
measure: Number of Subjects With Fatal Malaria Meeting Case Definition 1.
time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
description: Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).
measure: Number of Subjects With Fatal Malaria Meeting Case Definition 2.
time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
description: Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.
measure: Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as 'malaria', 'Plasmodium falciparum infection' or 'cerebral malaria". A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization.
measure: Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules.
measure: Number of Subjects With Meningitis SAEs
time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
description: For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'.
measure: Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)
time frame: At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)
description: Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points.
arm group label: GSK257049 Group
arm group type: Experimental
description: Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
arm group label: GSK257049 Comparator Group
arm group type: Active Comparator
description: Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
arm group label: VeroRab/Menjugate Comparator Group
arm group type: Active Comparator
description: Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
intervention type: Procedure
intervention name: Blood sampling
description: Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.
arm group label: GSK257049 Comparator Group
arm group label: GSK257049 Group
arm group label: VeroRab/Menjugate Comparator Group
intervention type: Biological
intervention name: Malaria Vaccine 257049 (MALARIA-055 PRI)
description: Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
arm group label: GSK257049 Comparator Group
arm group label: GSK257049 Group
intervention type: Biological
intervention name: Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
description: Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
arm group label: GSK257049 Comparator Group
arm group label: VeroRab/Menjugate Comparator Group
other name: Menjugate
intervention type: Biological
intervention name: Cell-culture rabies vaccine (MALARIA-055 PRI)
description: Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
arm group label: VeroRab/Menjugate Comparator Group
other name: VeroRab
intervention type: Biological
intervention name: TritanrixHepB/Hib (MALARIA-055 PRI)
description: Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
arm group label: GSK257049 Comparator Group
arm group label: GSK257049 Group
arm group label: VeroRab/Menjugate Comparator Group
intervention type: Biological
intervention name: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
description: Administered orally, during the MALARIA-055 study (NCT00866619).
arm group label: GSK257049 Comparator Group
arm group label: GSK257049 Group
arm group label: VeroRab/Menjugate Comparator Group
criteria: 
gender: All
minimum age: 42 Months
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
country: Burkina Faso
country: Kenya
country: Tanzania
citation: Tinto H, Otieno W, Gesase S, Sorgho H, Otieno L, Liheluka E, Valea I, Sing'oei V, Malabeja A, Valia D, Wangwe A, Gvozdenovic E, Guerra Mendoza Y, Jongert E, Lievens M, Roman F, Schuerman L, Lusingu J. Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial. Lancet Infect Dis. 2019 Aug;19(8):821-832. doi: 10.1016/S1473-3099(19)30300-7. Epub 2019 Jul 9.
PMID: 31300331
responsible party type: Sponsor
mesh term: Malaria
mesh term: Vaccines
sharing ipd: Yes
ipd description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com/Posting.aspx?ID=20045
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 