Phase 3
N=310
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
Hepatitis B · Polio · Diphtheria · Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT00315055 ↗Enrolled (actual)
310
Serious AEs
1.6%
Results posted
Feb 2014
Primary outcome: Primary: Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines — 94; 96 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DTaP-IPV-HB-PRP~T vaccine (Biological); DTaP-IPV//PRP~T combined (Biological); Hepatitis B vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines |
94; 96 | — |
| SECONDARY Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® |
65; 78; 91; 98; 73; 77 | — |
| SECONDARY Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® |
98; 98; 95; 94; 97; 100 | — |
| SECONDARY Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® |
55; 48; 100; 100; 65; 62 | — |
| SECONDARY Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® |
149; 265; 2.12; 2.37; 0.071; 0.091 | — |
| SECONDARY Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® |
70; 55; 66; 58; 57; 48 | — |
Summary
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
Immunogenicity
* To assess pre- and post-primary series
* To assess pre- and post-booster series.
Eligibility Criteria
Inclusion Criteria
- Two-month old infants of either gender 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 the parent(s) or other legal representative(s) and an institution official other than an investigator
- 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
- Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to 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 (except BCG) in the 4 weeks preceding the first trial vaccination
- Vaccination planned in the 4 weeks following trial vaccination
- History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
- Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
- Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of seizures
- Febrile (axillary temperature 37.4°C [rectal equivalent temperature >=38.0°C]) or acute illness on the day of inclusion.
Data sourced from ClinicalTrials.gov (NCT00315055). 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.