Phase 3
N=379
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
Diphtheria · Tetanus · Pertussis · Hepatitis B · Haemophilus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00343889 ↗Enrolled (actual)
379
Serious AEs
7.1%
Results posted
Dec 2013
Primary outcome: Primary: Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV — 146; 167 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DTaP-HB-PRP~T vaccine + OPV (Biological); Tritanrix-HepB/Hib™ + OPV vaccine (Biological); Oral Polio Vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
146; 167 | — |
| SECONDARY Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
54; 97 | — |
| 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 |
39.1; 86.2; 2.35; 7.82; 0.018; 0.018 | — |
| SECONDARY Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
137; 134; 13; 11; 184; 186 | — |
| SECONDARY Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
183; 168; 178; 116 | — |
| SECONDARY Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
123; 152; 7; 24; 100; 142 | — |
Summary
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.
The primary objective is:
* To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.
The secondary objectives are:
* To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and
* To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
Eligibility Criteria
Inclusion Criteria
- Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
- Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate)
- Able to attend all scheduled visits and to comply with all trial procedures.
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 corticosteroid therapy.
- Chronic illness at a stage that could interfere with the conduct or completion of the trial
- Blood or blood-derived products received since birth
- HB vaccination since birth
- Any vaccination in the four weeks preceding the first trial vaccination
- Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
- Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
- Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
- History of seizures
- Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Data sourced from ClinicalTrials.gov (NCT00343889). 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.