Immunogenicity Study of a DTaP-IPV-Hep B-PRP-T Combined Vaccine in Comparison to CombAct-Hib™ Concomitantly Administered with Engerix B™ Paediatric and OPV at 6, 10, and 14 weeks of Age in South African 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: EUCTR2011-004433-14-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

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: 715

Inclusion Criteria

1) 0 to 3 day old infants
2) Mother sero-negative for Human Immunodeficiency Virus (HIV) after 24 weeks’ gestation
3) Born at full-term of pregnancy (=37 weeks, assessed by a physician at the time of birth) with a birth weight =2.5 kg
4) Apgar score >7 at 5 or 10 minutes of life
5) Informed Consent Form (ICF) signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian was illiterate
6) Able to attend all scheduled visits and to comply with all trial procedures
7) For the booster phase only: Informed Consent Form (Addendum 1 to the ICF, see Appendix 4) signed by a parent or legal guardian, and by an independent witness if the parent / legal guardian was illiterate (collected before or at V07). This inclusion criterion had to be checked at V07 only.
8) For the booster phase only: Toddlers aged 15 to 18 months on the day of inclusion (range: 456 to 578 days of age, inclusive). This inclusion criterion had to be checked at V07.
Are the trial subjects under 18? yes
Number of subjects for this age range: 715
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) Current or planned participation in another clinical trial during the entire duration of the present trial
2) Suspected congenital or acquired immunodeficiency
3) Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history.
4) Chronic illness at a stage that could have interfered with trial conduct or completion.
5) Blood or blood-derived products received since birth
6) Any planned vaccination (except BCG vaccination and trial vaccinations) from birth to V05 (18 weeks of age)
7) Oral poliovirus vaccine administration at birth
8) Known maternal history of HIV, Hep B (HBsAg), or hepatitis C seropositivity
9) Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
10) History of seizures
11) Febrile (axillary temperature =37.4°C) or acute illness on the day of inclusion

Study & Design

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