Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diphtheria
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 2133
- Locations
- 1
- Primary Endpoint
- Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At Screening:
- •0 to 3 day old infants
- •Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- •Apgar score ≥ 7 at three minutes after birth
- •Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
- •At Inclusion:
- •Six weeks of age
- •Received a dose of Hepatitis B (HB) in the first three days of life
- •Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
- •At Screening:
- •Illness at a stage that could interfere with trial conduct or completion
- •Any vaccination before HB vaccination (except bacille Calmette-Guérin \[BCG\] given at birth)
- •Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
- •Acute illness on the day of screening.
- •At Screening and at Inclusion:
- •Blood or blood-derived products received since birth
- •Planned participation in another clinical trial during the present trial period
- •Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
- •Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Outcomes
Primary Outcomes
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Time Frame: 1 month post third vaccination
Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.
Time Frame: Day 0 to Day 7 post-vaccination
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
Secondary Outcomes
- Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV(Day 0 to Day 7 after vaccination)
- Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV(1 month post third vaccination)