Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2, 3, and 4 Months Primary Schedule in Healthy Turkish Infants

Sanofi Pasteur, a Sanofi Company0 sites310 target enrollmentJuly 2006

ConditionsHepatitis B Polio Diphtheria Pertussis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hepatitis B
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 310
Primary Endpoint: 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
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

February 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: Day 90 post first dose

Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.

Secondary Outcomes

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®(Day 90 post first dose)
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®(Day 90 post first dose)
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®(Day 0 (pre-vaccination) and Day 30 post-dose 3)
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®(Day 0 to Day 7 post any dose)
Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®(Day 90 (30 Days post-dose 3))