Immunogenicity Study of a DTaP-IPV-Hep B-PRP-T Combined Vaccine in Comparison to Infanrix hexa™, Both Concomitantly Administered with Prevnar™ at 2, 4, and 6 Months of Age in Thai Infants

• Conditions: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus; MedDRA version: 14.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004457-87-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

1) Two-month-old infant (50 to 71 days old) on the day of inclusion, of either gender
2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
3) Hepatitis B vaccination since birth
4) Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate
5) Able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 412
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
2) Planned participation in another clinical trial during the present trial period
3) Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
4) Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy
5) Chronic illness at a stage that could interfere with trial conduct or completion
6) Blood or blood-derived products received since birth
7) Any vaccination in the 4 weeks preceding the first trial vaccination
8) Any planned vaccination (except trial vaccinations) during the trial
9) Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) confirmed either clinically, serologically, or microbiologically
10) Previous vaccination against pertussis, T, D, poliomyelitis, Hib infection(s) or Streptococcus pneumoniae
11) Known personal or maternal history of Human Immunodeficiency Virus (HIV), Hep B (HBsAg carrier), or Hepatitis C seropositivity
12) Known thrombocytopenia or bleeding disorder contraindicating IM vaccination
13) History of seizures
14) Febrile (rectal equivalent temperature =38.0°C) or acute illness on the day of inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP-T combined vaccine induces an immune response that is at least as good as the response following Infanrix hexa™ in terms of seroprotection rates to Hep B and PRP, 1 month after a three-dose primary series (at 2, 4, and 6 months), when co-administered with Prevnar™.;Secondary Objective: Immunogenicity:<br>To describe in each group the immunogenicity parameters of each vaccine component (for DTaP-IPV-Hep B-PRP-T and Infanrix hexa™) at V06.<br>Safety:<br>To describe the overall safety after each injection.;Primary end point(s): The primary endpoints were the seroprotection rates as assessed 1 month after the third dose of the primary series (i.e. at V06), with seroprotection being defined as:<br>- Anti-Hep B antibody (Ab) titers =10 mIU/mL<br>- Anti-PRP Ab titers =0.15 µg/mL;Timepoint(s) of evaluation of this end point: Blood samples for immunogenicity testing were collected at Day 0 and Day 150.