arge Scale Safety Study of a DTaP-IPV-Hep B-PRP-T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American 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: EUCTR2011-004431-31-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: 2133

Inclusion Criteria

1) Two-month-old infants (50 to 71 days old inclusive) on the day of inclusion
2) Born at full term of pregnancy (=37 weeks) with a birth weight =2.5 kg
3) Informed Consent Form signed by one or both parents, or by a legally acceptable representative, and one or two independent witnesses. (In Peru, parents/legally acceptable representatives' finger print and an independent witness' signature were required if the parents/legally acceptable representative was illiterate)
4) Able to attend all scheduled visits and to comply with all trial procedures
5) Had complied with the national immunization calendar (Bacille Calmette-Guérin [BCG] for both countries) for the first 2 months of life (e.g. Mexico: no dose of Hep B vaccine since birth; Peru: one dose of Hep B vaccine at birth)
Are the trial subjects under 18? yes
Number of subjects for this age range: 2133
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) Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroids therapy
4) Subjects with congenital or acquired immunodeficiency in the child's surroundings
5) 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
6) Chronic illness at a stage that could have interfered with trial conduct or completion
7) Blood or blood-derived products received since birth
8) Any vaccination in the 4 weeks preceding the first trial vaccination
9) Vaccination planned in the 4 weeks following the trial vaccination
10) Documented history of pertussis, T, D, poliomyelitis (polio), Hib, or Hep B infection(s) (confirmed either clinically, serologically, or microbiologically)
11) Mother known as seropositive for human immunodeficiency virus or hepatitis C, or known carrier of HBs Ag
12) Previous vaccination against pertussis, T, D, polio, or Hib infection(s)
13) Coagulopathy, thrombocytopenia, or a bleeding disorder contraindicating IM vaccination
14) History of seizures
15) 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