Phase 3
N=2,133
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
Diphtheria · Tetanus · Pertussis · Hepatitis B · Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00348881 ↗Enrolled (actual)
2,133
Serious AEs
2.0%
Results posted
Oct 2013
Primary outcome: Primary: 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 — 239; 119; 210; 121 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DTaP-HB-PRP~T combined vaccine (Biological); Tritanrix-HepB/Hib™ vaccine (Biological); Oral poliomyelitis vaccine (OPV) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
239; 119; 210; 121; 217; 109 | — |
| PRIMARY 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. |
5; 8; 3; 1; 1; 3 | — |
| SECONDARY 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 |
464; 343; 3.02; 10.3; 0.025; 0.023 | — |
| SECONDARY 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 |
1092; 636; 344; 295; 958; 573 | — |
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.
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
- Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)
At Inclusion:
- Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
- Participation in another clinical trial before the first trial vaccination
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
- 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
- Chronic illness at a stage that could interfere with trial conduct or completion
- Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
- Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
- History of seizures
- Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Data sourced from ClinicalTrials.gov (NCT00348881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.