Brief Title
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
Brief Summary
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi
Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary
vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of
life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine
Condition
Diphtheria
Intervention
Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
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
186
Start Date
December 2005
Completion Date
January 2009
Primary Completion Date
September 2007
Eligibility Criteria
Inclusion Criteria:
- Aged 53 to 70 days inclusive on the day of inclusion
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 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.
- Mother known as seropositive to HIV or hepatitis B
- Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille
Calmette-Guerin [BCG])
- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type
b infection or hepatitis B (confirmed either clinically, serologically or
microbiologically).
- Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis
diseases or Haemophilus influenzae 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
2 Months - 2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Clinical Trials, ,
Location Countries
Thailand
Location Countries
Thailand
Administrative Informations
NCT ID
NCT00255021
Organization ID
E2I34
Responsible Party
Sponsor
Study Sponsor
Sanofi
Study Sponsor
Clinical Trials, Study Director, Sanofi Pasteur, a Sanofi Company
Verification Date
April 2012