Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

Brief Title

Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

Official Title

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

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 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

Condition

Diphtheria

Intervention

DTaP-HB-PRP~T vaccine + OPV

Study Arms / Comparison Groups

 Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine

Description:  Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

379

Start Date

August 2006

Completion Date

April 2008

Primary Completion Date

November 2007

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.
      

Gender

All

Ages

42 Days - 50 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

Philippines

Location Countries

Philippines

NCT ID

NCT00343889

Organization ID

AL203

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company

Study Sponsor

Medical Director, Study Director, Sanofi Pasteur Inc.

Verification Date

November 2013