Brief Title
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
Official Title
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2, 3, and 4 Months Primary Schedule in Healthy Turkish Infants
Brief Summary
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series. Immunogenicity - To assess pre- and post-primary series - To assess pre- and post-booster series.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines
Secondary Outcome
Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
Condition
Hepatitis B
Intervention
DTaP-IPV-HB-PRP~T vaccine
Study Arms / Comparison Groups
Group 1: DTaP-IPV-Hep B-PRP-T
Description: Participants will receive 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T); One dose each at 2, 3, and 4 months 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 Information
Recruitment Status
Biological
Estimated Enrollment
310
Start Date
July 2006
Completion Date
February 2008
Primary Completion Date
July 2007
Eligibility Criteria
Inclusion Criteria: - Two-month old infants of either gender 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 the parent(s) or other legal representative(s) and an institution official other than an investigator - 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 - 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 since birth - Any vaccination (except BCG) in the 4 weeks preceding the first trial vaccination - Vaccination planned in the 4 weeks following trial vaccination - History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) - Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity - Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s) - Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination - History of seizures - Febrile (axillary temperature 37.4°C [rectal equivalent temperature >=38.0°C]) or acute illness on the day of inclusion.
Gender
All
Ages
50 Days - 71 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Clinical Trials, ,
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT00315055
Organization ID
A3L10
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Clinical Trials, Study Director, Sanofi Pasteur, a Sanofi Company
Verification Date
September 2014