Brief Title
Immunogenicity and Safety of Pentaxim™ in an Indian Population
Official Title
Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.
Brief Summary
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life. Safety: This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
Condition
Diphtheria
Intervention
Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
Study Arms / Comparison Groups
1
Description:
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
226
Start Date
February 2006
Completion Date
December 2008
Primary Completion Date
April 2008
Eligibility Criteria
Inclusion Criteria: - Aged 42 to 56 days inclusive on the day of inclusion - Born at full term pregnancy (> 37 weeks) with a birth weight ≥ 2.5 kg - Informed consent form signed by the parent(s) or other legal representative - 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 corticosteroids therapy - Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or 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 past. - Any vaccination preceding the trial vaccination (except BCG and hepatitis B) - History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically). - Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine. - Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination - History of/current seizures - Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
Gender
All
Ages
42 Days - 56 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT00259337
Organization ID
E2I41
Responsible Party
Sponsor
Study Sponsor
Sanofi
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
April 2012