Phase 3
Completed N=379
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
Source: ClinicalTrials.gov NCT00343889 ↗Enrolled (actual)
379
Serious AEs
7.1%
Results posted
Dec 2013
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.