Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants

Sanofi Pasteur, a Sanofi Company0 sites2,133 target enrollmentJuly 2006

ConditionsDiphtheria Tetanus Pertussis Haemophilus Influenzae Type b Hepatitis B

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diphtheria
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 2133
Primary Endpoint: 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.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

February 2008

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

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.

Time Frame: Day 0 up to Day 7 post-injection

High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.

Secondary Outcomes

Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo(Day 30 post-dose 3)
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(Day 30 post-dose 3)
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination(Day 0 up to Day 7 Post-injection)