Phase 3
N=2,133
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
Diphtheria · Tetanus · Pertussis · Haemophilus Influenzae Type b · Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00313911 ↗Enrolled (actual)
2,133
Serious AEs
6.4%
Results posted
Nov 2012
Primary outcome: Primary: Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. — 56; 39; 5; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DTaP-IPV-HB-PRP~T (Biological); Tritanrix-HepB/Hib (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. |
56; 39; 5; 4; 25; 15 | — |
| SECONDARY Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo |
1075; 3376 | — |
| SECONDARY Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo |
100; 100; 96; 99 | — |
| SECONDARY Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination |
831; 574; 175; 193; 744; 506 | — |
Summary
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.
To evaluate the overall safety in terms of:
Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.
Immunogenicity:
To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.
Eligibility Criteria
Inclusion Criteria
- 2 months old infants on the day of inclusion
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses
- Able to attend all scheduled visits and to comply with all trial procedures
- Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.
Exclusion Criteria
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Subjects with congenital or acquired immunodeficiency in the child's surrounding
- 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
- Blood or blood-derived products received since birth
- Any vaccination in the 4 weeks preceding the first trial vaccination
- Vaccination planned in the 4 weeks following the trial vaccination
- Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
- Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
- Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination
- History of seizures
- Febrile or acute illness on the day of inclusion.
Data sourced from ClinicalTrials.gov (NCT00313911). 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.