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 Information
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
Administrative Informations
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