Immunogenicity of DTaP-IPV-Hep B-PRP-T Combined Vaccine Compared with PENTAXIM™ and ENGERIX B® at 2-3-4 Months Primary Schedule in Healthy TurkishInfants

• 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: EUCTR2011-004454-26-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: 310

Inclusion Criteria

1) Two-month old infants (from the 50th to the 71st day inclusive) of either gender 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 the parent(s) or other legal representative(s) and an institution official other than an Investigator
4) 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: 310
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, immunosuppressive therapy such as long-term systemic corticosteroid therapy
4) Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
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 (except Bacillus Calmette-Guerin [BCG]) in the 4 weeks preceding the first trial vaccination
8) Vaccination planned in the 4 weeks following trial vaccination
9) History of documented pertussis, T, D, polio, HiB, or Hep B infection(s) (confirmed either clinically, serologically or microbiologically)
10) Known personal or maternal history of human immunodeficiency virus (HIV), HBsAg, or hepatitis C seropositivity
11) Previous vaccination against pertussis, T, D, polio, Hib, and Hep B infection(s)
12) Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM
vaccination
13) History of seizures
14) Febrile (axillary temperature 37.4°C [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