Immunogenicity Study of DTaP-IPV-Hep B-PRP-T Combined Vaccine in Comparison to Infanrix hexa™, at 2-4-6 Months of Age in Healthy Peruvian 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: EUCTR2011-004434-33-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: 266

Inclusion Criteria

1) Two months 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) Mother negative for HBsAg in approximately the last 30 days of pregnancy (=36 weeks of amenorrhea) or in the 30 days post-partum
4) Informed consent form signed by both parents. If one or both parent(s) are under 18 years of age, the subject’s grandparent(s) should also sign. An independent witness should also sign if the parent(s)/grandparent(s) are illiterate
5) Able to attend all scheduled visits and to comply with all trial procedures
6) Received Bacillus Calmette-Guerin (BCG) vaccine between birth and 1 month of life in agreement with the national immunization calendar
Are the trial subjects under 18? yes
Number of subjects for this age range: 266
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) Known 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 (for more than 2 weeks) systemic corticosteroid therapy within the last four weeks
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 during the trial (until V06), except the study vaccines, rotavirus vaccine, and pneumococcal conjugate vaccines
9) Documented history of pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection(s) (confirmed either clinically, serologically, or microbiologically)
10) Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s)
11) Known personal or maternal history of Human Immunodeficiency Virus, hepatitis B or hepatitis C seropositivity
12) Known thrombocytopenia or bleeding disorder contraindicating IM vaccination
13) History of seizures
14) Febrile (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