Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants

Brief Title

Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants

Official Title

Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine at 12 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants Having Received Hepatitis B Vaccine at Birth

Brief Summary

      DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs
      for immunization in infancy, while offering the benefit of a reduced number of injections,
      and potentially of an increased acceptance.

      Primary Objectives:

        -  To describe the antibody persistence at 12 to 18 months following a three-dose primary
           series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14
           weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.

        -  To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18
           months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or
           Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine
           given at birth.

      Secondary Objective:

        -  To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when
           administered concomitantly with Oral Polio Vaccine (OPV).
    

Detailed Description

      This study will assess the immunogenicity and reactogenicity of the investigational
      DTaP-HB-PRP~T combined vaccine when given as a booster dose, concomitantly with OPV, in
      Filipino children previously primed at 6, 10, and 14 weeks with the investigational
      DTaP-HB-PRP~T combined vaccine or Tritanrix-Hep B/Hib™ vaccine and having received a first
      dose of Hep B vaccine (Recomvax B™) at birth in a previous study, AL201 (NCT00348881).
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)

Secondary Outcome

 Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)

Condition

Diphtheria

Intervention

DTaP-HB PRP~T Combined Vaccine

Study Arms / Comparison Groups

 Group 1

Description:  DTaP-Hep B-PRP-T + OPV vaccine group

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

1843

Start Date

September 2007

Completion Date

April 2009

Primary Completion Date

December 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578
             days of age inclusive)

          -  Participated in the AL201 study and completed the three-dose primary series with
             either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age,
             and received hepatitis B vaccine at birth

          -  Informed consent form signed by one parent or legal representative if appropriate
             (independent witness 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 trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term
             (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months

          -  Known 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 in the last 3 months

          -  Any vaccination in the 4 weeks preceding the trial vaccination

          -  Vaccination planned in the 4 weeks following the trial vaccination

          -  Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion

          -  History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b,
             hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically,
             or microbiologically)

          -  Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus
             influenzae type b, hepatitis B or poliovirus 3 types antigen, since the end of the
             primary series

          -  Thrombocytopenia or a bleeding disorder contraindicating IM vaccination

          -  Serious adverse event related to any vaccination in the AL201 study.
      

Gender

All

Ages

12 Months - 18 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

Philippines

Location Countries

Philippines

NCT ID

NCT00514709

Organization ID

AL204

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company

Study Sponsor

Medical Director, Study Director, Sanofi Pasteur Inc.

Verification Date

July 2016