Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepB/Hib™, Both Given Concomitantly With the Oral Polio Vaccine at 6, 10, and 14 Weeks of Age in Healthy Infants in the Philippines

Sanofi Pasteur, a Sanofi Company0 sites379 target enrollmentAugust 2006

ConditionsDiphtheria Tetanus Pertussis Hepatitis B Haemophilus Infections

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diphtheria
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 379
Primary Endpoint: 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
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

April 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

•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

Outcomes

Primary Outcomes

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

Time Frame: 1 month post third vaccination

Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.

Secondary Outcomes

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(1 month post third vaccination)
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(1 month post third vaccination)
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(1 month post third vaccination)
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(1 month post third vaccination)
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(Day 0 up to Day 7 after each vaccination)