<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/NCT04429295</url>
  </required_header>
  <id_info>
    <org_study_id>SH600009</org_study_id>
    <secondary_id>U1111-1233-9694</secondary_id>
    <nct_id>NCT04429295</nct_id>
  </id_info>
  <brief_title>Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand</brief_title>
  <official_title>Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (Shan6™) Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with&#xD;
      bOPV and IPV vaccines when coadministered with PCV and ORV&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
        -  To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant&#xD;
           vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV)&#xD;
&#xD;
        -  To describe the immune response to co-administered ORV-1 (Rotarix™) in a subset of&#xD;
           participants from each group&#xD;
&#xD;
        -  To describe the immune response to co-administered PCV-13 (Prevnar 13®) in a subset of&#xD;
           participants from each group&#xD;
&#xD;
        -  To describe the persistence of the antibodies against SHAN6™ antigens following a 3-dose&#xD;
           primary series of SHAN6™ or SHAN5™ given with bOPV and IPV&#xD;
&#xD;
        -  To describe the immunogenicity profile of SHAN6™ 28 days after the single booster dose&#xD;
           of SHAN6™&#xD;
&#xD;
        -  To describe the safety profile of the SHAN6™ vaccine and the control vaccines (SHAN5™&#xD;
           given with bOPV and IPV), when administered concomitantly with routine pediatric&#xD;
           vaccines&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of each participant's active participation in the study will be approximately&#xD;
      14-17 months (416-506 days)&#xD;
&#xD;
      in addition to the 2 MedDRA terms: Polio immunisation 10054175 Hepatitis B immunisation&#xD;
      10054181 Haemophilus influenzae type B immunisation 10069533 Tetanus immunisation 10054131&#xD;
      Rotavirus immunisation 10076886 Pneumococcal immunisation 10069578&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2020</start_date>
  <completion_date type="Actual">November 20, 2021</completion_date>
  <primary_completion_date type="Actual">February 26, 2021</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>Number of participants with antibodies (Ab) above predefined threshold against diphtheria (D), tetanus (T), hepatitis B (Hep B), Haemophilus influenzae type b (Hib) and poliovirus (Polio) antigens</measure>
    <time_frame>28 days after the third dose (Day 148)</time_frame>
    <description>Ab titers against D, T, Hep B, Hib and Polio antigens will be measured Threshold values will be considered</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens</measure>
    <time_frame>28 days after the third dose (Day 148)</time_frame>
    <description>Ab against pertussis antigens will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Ab titers above predefined thresholds against each antigen diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens</measure>
    <time_frame>At baseline (Day 0) and 28 days after the third dose (Day 148)</time_frame>
    <description>Ab titers against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a vaccine response for pertussis antigens</measure>
    <time_frame>At baseline (Day 0) and 28 days after the third dose (Day 148)</time_frame>
    <description>Pertussis antigens vaccine response Threshold values will be considered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pertussis antigens vaccine seroconversion</measure>
    <time_frame>At baseline (Day 0) and 28 days after the third dose (Day 148)</time_frame>
    <description>Ab against pertussis antigens will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentrations Ratios (GMCRs) of Ab against all the antigens, including anti-rotavirus and anti-S. pneumoniae in a subset of participants</measure>
    <time_frame>At baseline (Day 0) and 28 days after the third dose (Day 148)</time_frame>
    <description>Ab concentrations against all the antigens, including anti-rotavirus and anti-S. pneumoniae for a subset of participants, will be measured The ratio calculated will be: (post dose 3/pre-primary)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMCs of Ab against each antigen, including anti-rotavirus and anti-pneumococcal serotypes, in a subset of participants</measure>
    <time_frame>At baseline (Day 0) and 28 days after the third dose (Day 148)</time_frame>
    <description>Ab concentrations against each antigen, including anti rotavirus and anti pneumococcal serotypes for a subset of participants, will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with anti-rotavirus Ab titers above predefined thresholds in a subset of participants</measure>
    <time_frame>At baseline (Day 0) and 28 days after the third dose (Day 148)</time_frame>
    <description>Ab against rotavirus will be measured in a subset of participants Threshold values will be considered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with anti-pneumococcal Ab titers above predefined thresholds in a subset of participants</measure>
    <time_frame>At baseline (Day 0) and 28 days after the third dose (Day 148)</time_frame>
    <description>Anti-pneumococcal Ab will be measured in a subset of participants Threshold values will be considered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Ab titers above predefined threshold against diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens</measure>
    <time_frame>Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)</time_frame>
    <description>Ab against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a booster response for pertussis antigens</measure>
    <time_frame>Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)</time_frame>
    <description>Pertussis antigens booster response Threshold values will be considered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pertussis antigens vaccine seroconversion</measure>
    <time_frame>Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)</time_frame>
    <description>Ab against pertussis antigens will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMCRs of Ab against all the antigens</measure>
    <time_frame>Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)</time_frame>
    <description>Ab concentrations against all the antigens will be measured The ratio calculated will be: (post booster/pre-booster)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMCs of Ab against each antigen</measure>
    <time_frame>Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)</time_frame>
    <description>Ab concentrations against each antigen will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>aGMCs of Ab against pertussis antigens</measure>
    <time_frame>Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)</time_frame>
    <description>Ab against pertussis antigens will be measured, adjusted for baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants reporting immediate systemic adverse events (AEs)</measure>
    <time_frame>Within 30 minutes post-vaccination</time_frame>
    <description>Unsolicited (spontaneously reported) systemic AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants reporting solicited injection site and systemic reactions</measure>
    <time_frame>Up to 7 days post-vaccination</time_frame>
    <description>Solicited injection site reactions:&#xD;
- tenderness, erythema and site swelling&#xD;
Solicited systemic reactions:&#xD;
- fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants reporting unsolicited non-serious AEs</measure>
    <time_frame>Up to 28 days post-vaccination</time_frame>
    <description>Unsolicited non-serious AEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants reporting serious adverse events (SAEs)</measure>
    <time_frame>Up to Day 416-506</time_frame>
    <description>SAEs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">460</enrollment>
  <condition>Pertussis Immunisation</condition>
  <condition>Diphtheria Immunisation</condition>
  <condition>Polio Immunisation</condition>
  <condition>Hepatitis B Immunisation</condition>
  <condition>Haemophilus Influenzae Type B Immunisation</condition>
  <condition>Tetanus Immunisation</condition>
  <condition>Rotavirus Immunisation</condition>
  <condition>Pneumococcal Immunisation</condition>
  <arm_group>
    <arm_group_label>Group A - Intervention regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SHAN6™ + routine pediatric vaccines pneumococcal 13-valent conjugate vaccine [PCV] [Prevnar 13®] and oral rotavirus vaccine [ORV-1] [Rotarix™] at age of 2, 4 months; SHAN6™ + Prevnar 13® at age of 6 months; SHAN6™ administered alone as a booster dose at age of 15-18 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - Control regimen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine [IPV] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus)</intervention_name>
    <description>Pharmaceutical form:Suspension for injection Route of administration: Intramuscular</description>
    <arm_group_label>Group A - Intervention regimen</arm_group_label>
    <arm_group_label>Group B - Control regimen</arm_group_label>
    <other_name>SHAN6™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b)</intervention_name>
    <description>Pharmaceutical form:Suspension for injection Route of administration: Intramuscular</description>
    <arm_group_label>Group B - Control regimen</arm_group_label>
    <other_name>SHAN5™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Inactivated Poliomyelitis Vaccine</intervention_name>
    <description>Pharmaceutical form:Suspension for injection Route of administration: Intramuscular</description>
    <arm_group_label>Group B - Control regimen</arm_group_label>
    <other_name>IMOVAX Polio</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Poliomyelitis Vaccine bivalent types 1 and 3</intervention_name>
    <description>Pharmaceutical form:Oral suspension Route of administration: Oral</description>
    <arm_group_label>Group B - Control regimen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human Rotavirus, live attenuated</intervention_name>
    <description>Pharmaceutical form:Oral suspension Route of administration: Oral</description>
    <arm_group_label>Group A - Intervention regimen</arm_group_label>
    <arm_group_label>Group B - Control regimen</arm_group_label>
    <other_name>Rotarix™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)</intervention_name>
    <description>Pharmaceutical form:Suspension for injection Route of administration: Intramuscular</description>
    <arm_group_label>Group A - Intervention regimen</arm_group_label>
    <arm_group_label>Group B - Control regimen</arm_group_label>
    <other_name>Prevnar 13®, PCV-13</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Aged ≥ 2 months (age range of 8 weeks &lt;12 weeks) on the day of the first vaccination&#xD;
&#xD;
          -  Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or&#xD;
             medically stable prematurely born infants (born after a gestational period of 27-36&#xD;
             weeks)&#xD;
&#xD;
          -  Infants who have received the birth dose of Bacille Calmette-Guérin vaccine (BCG) at&#xD;
             least 4 weeks before the first trial vaccination&#xD;
&#xD;
          -  Participant and parent(s)/legally acceptable representative(s) are able to attend all&#xD;
             scheduled visits and comply with all study procedures&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Participation at the time of study enrollment (or in the 4 weeks preceding the first&#xD;
             trial vaccination) or planned participation during the present trial period in another&#xD;
             clinical trial investigating a vaccine, drug, medical device, or medical procedure&#xD;
&#xD;
          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned&#xD;
             receipt of any vaccine within the period of 4 weeks before to 4 weeks after each trial&#xD;
             vaccination, except for oral polio vaccine (OPV) and influenza vaccination. OPV may be&#xD;
             received any time during the study while influenza vaccination may be received at a&#xD;
             gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception&#xD;
             includes monovalent pandemic influenza vaccines and multivalent influenza vaccines&#xD;
&#xD;
          -  Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B (except the&#xD;
             dose of Hep B vaccine given at birth or at least 4 weeks before the first trial&#xD;
             vaccination), Haemophilus influenzae type b, poliomyelitis (except OPV), rotavirus,&#xD;
             and Streptococcus pneumoniae with either the trial vaccines or another vaccine&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products since birth&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since&#xD;
             birth; or long-term systemic corticosteroid therapy (prednisone or equivalent at ≥ 0.5&#xD;
             mg/kg/day for more than 2 consecutive weeks since birth)&#xD;
&#xD;
          -  Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B&#xD;
             (HBsAg positive), or hepatitis C (hepatitis C virus [HCV] ribonucleic acid [RNA]&#xD;
             positive)&#xD;
&#xD;
          -  Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant&#xD;
             neoplasms affecting the bone marrow or lymphatic systems&#xD;
&#xD;
          -  History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus&#xD;
             influenzae type b, rotavirus, or pneumococcal infection(s) confirmed either&#xD;
             clinically, serologically, or microbiologically&#xD;
&#xD;
          -  History of any neurologic disorders, including encephalopathy, seizures (febrile and&#xD;
             non-febrile) and progressive neurologic disorders&#xD;
&#xD;
          -  History of intussusception&#xD;
&#xD;
          -  In an emergency setting, or hospitalized&#xD;
&#xD;
          -  Known systemic hypersensitivity to any of the vaccine components or history of a&#xD;
             life-threatening reaction to the vaccines used in the trial or to a vaccine containing&#xD;
             any of the same substances&#xD;
&#xD;
          -  Thrombocytopenia, as reported by the parent/legally acceptable representative,&#xD;
             contraindicating intramuscular vaccination in the Investigator's opinion&#xD;
&#xD;
          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             contraindicating intramuscular vaccination in the Investigator's opinion&#xD;
&#xD;
          -  Chronic illness that, in the Investigator's opinion, is at a stage where it might&#xD;
             interfere with trial conduct or completion&#xD;
&#xD;
          -  Any condition which, in the Investigator's opinion, might interfere with the&#xD;
             evaluation of the study objectives&#xD;
&#xD;
          -  Moderate or severe acute illness/infection (according to the Investigator's judgment)&#xD;
             on the day of vaccination or febrile illness (axillary temperature ≥ 38.0 C). A&#xD;
             prospective participant should not be included in the study until the condition has&#xD;
             resolved or the febrile event has subsided&#xD;
&#xD;
          -  Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first&#xD;
             blood draw&#xD;
&#xD;
          -  Identified as a natural or adopted child of the Investigator, relatives or employee&#xD;
             with direct involvement in the proposed study&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Weeks</minimum_age>
    <maximum_age>11 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur, a Sanofi Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 7640003</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7640001</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 7640002</name>
      <address>
        <city>Khon Kaen</city>
        <zip>4002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Diphtheria</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>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04429295
org study id: SH600009
secondary id: U1111-1233-9694
nct id: NCT04429295
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary Objective:

      To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with
      bOPV and IPV vaccines when coadministered with PCV and ORV

      Secondary Objective:

        -  To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant
           vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV)

        -  To describe the immune response to co-administered ORV-1 (Rotarix™) in a subset of
           participants from each group

        -  To describe the immune response to co-administered PCV-13 (Prevnar 13®) in a subset of
           participants from each group

        -  To describe the persistence of the antibodies against SHAN6™ antigens following a 3-dose
           primary series of SHAN6™ or SHAN5™ given with bOPV and IPV

        -  To describe the immunogenicity profile of SHAN6™ 28 days after the single booster dose
           of SHAN6™

        -  To describe the safety profile of the SHAN6™ vaccine and the control vaccines (SHAN5™
           given with bOPV and IPV), when administered concomitantly with routine pediatric
           vaccines
The duration of each participant's active participation in the study will be approximately
      14-17 months (416-506 days)

      in addition to the 2 MedDRA terms: Polio immunisation 10054175 Hepatitis B immunisation
      10054181 Haemophilus influenzae type B immunisation 10069533 Tetanus immunisation 10054131
      Rotavirus immunisation 10076886 Pneumococcal immunisation 10069578
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants with antibodies (Ab) above predefined threshold against diphtheria (D), tetanus (T), hepatitis B (Hep B), Haemophilus influenzae type b (Hib) and poliovirus (Polio) antigens
time frame: 28 days after the third dose (Day 148)
description: Ab titers against D, T, Hep B, Hib and Polio antigens will be measured Threshold values will be considered
measure: Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens
time frame: 28 days after the third dose (Day 148)
description: Ab against pertussis antigens will be measured
measure: Number of participants with Ab titers above predefined thresholds against each antigen diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens
time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
description: Ab titers against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered
measure: Number of participants with a vaccine response for pertussis antigens
time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
description: Pertussis antigens vaccine response Threshold values will be considered
measure: Pertussis antigens vaccine seroconversion
time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
description: Ab against pertussis antigens will be measured
measure: Geometric Mean Concentrations Ratios (GMCRs) of Ab against all the antigens, including anti-rotavirus and anti-S. pneumoniae in a subset of participants
time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
description: Ab concentrations against all the antigens, including anti-rotavirus and anti-S. pneumoniae for a subset of participants, will be measured The ratio calculated will be: (post dose 3/pre-primary)
measure: GMCs of Ab against each antigen, including anti-rotavirus and anti-pneumococcal serotypes, in a subset of participants
time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
description: Ab concentrations against each antigen, including anti rotavirus and anti pneumococcal serotypes for a subset of participants, will be measured
measure: Number of participants with anti-rotavirus Ab titers above predefined thresholds in a subset of participants
time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
description: Ab against rotavirus will be measured in a subset of participants Threshold values will be considered
measure: Number of participants with anti-pneumococcal Ab titers above predefined thresholds in a subset of participants
time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
description: Anti-pneumococcal Ab will be measured in a subset of participants Threshold values will be considered
measure: Number of participants with Ab titers above predefined threshold against diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens
time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
description: Ab against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered
measure: Number of participants with a booster response for pertussis antigens
time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
description: Pertussis antigens booster response Threshold values will be considered
measure: Pertussis antigens vaccine seroconversion
time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
description: Ab against pertussis antigens will be measured
measure: GMCRs of Ab against all the antigens
time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
description: Ab concentrations against all the antigens will be measured The ratio calculated will be: (post booster/pre-booster)
measure: GMCs of Ab against each antigen
time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
description: Ab concentrations against each antigen will be measured
measure: aGMCs of Ab against pertussis antigens
time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
description: Ab against pertussis antigens will be measured, adjusted for baseline value
measure: Number of participants reporting immediate systemic adverse events (AEs)
time frame: Within 30 minutes post-vaccination
description: Unsolicited (spontaneously reported) systemic AEs
measure: Number of participants reporting solicited injection site and systemic reactions
time frame: Up to 7 days post-vaccination
description: Solicited injection site reactions:
- tenderness, erythema and site swelling
Solicited systemic reactions:
- fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability
measure: Number of participants reporting unsolicited non-serious AEs
time frame: Up to 28 days post-vaccination
description: Unsolicited non-serious AEs
measure: Number of participants reporting serious adverse events (SAEs)
time frame: Up to Day 416-506
description: SAEs
arm group label: Group A - Intervention regimen
arm group type: Experimental
description: SHAN6™ + routine pediatric vaccines pneumococcal 13-valent conjugate vaccine [PCV] [Prevnar 13®] and oral rotavirus vaccine [ORV-1] [Rotarix™] at age of 2, 4 months; SHAN6™ + Prevnar 13® at age of 6 months; SHAN6™ administered alone as a booster dose at age of 15-18 months
arm group label: Group B - Control regimen
arm group type: Active Comparator
description: SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine [IPV] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age
intervention type: Biological
intervention name: DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus)
description: Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
arm group label: Group A - Intervention regimen
arm group label: Group B - Control regimen
other name: SHAN6™
intervention type: Biological
intervention name: DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b)
description: Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
arm group label: Group B - Control regimen
other name: SHAN5™
intervention type: Biological
intervention name: Inactivated Poliomyelitis Vaccine
description: Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
arm group label: Group B - Control regimen
other name: IMOVAX Polio
intervention type: Biological
intervention name: Poliomyelitis Vaccine bivalent types 1 and 3
description: Pharmaceutical form:Oral suspension Route of administration: Oral
arm group label: Group B - Control regimen
intervention type: Biological
intervention name: Human Rotavirus, live attenuated
description: Pharmaceutical form:Oral suspension Route of administration: Oral
arm group label: Group A - Intervention regimen
arm group label: Group B - Control regimen
other name: Rotarix™
intervention type: Biological
intervention name: Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
description: Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
arm group label: Group A - Intervention regimen
arm group label: Group B - Control regimen
other name: Prevnar 13®, PCV-13
criteria: 
gender: All
minimum age: 8 Weeks
maximum age: 11 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi Pasteur, a Sanofi Company
facility: 
facility: 
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Diphtheria
mesh term: Vaccines
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org