Status:
COMPLETED
Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
Lead Sponsor:
Sanofi
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
2-2 years
Phase:
PHASE4
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, ...
Eligibility Criteria
Inclusion
- Aged 53 to 70 days inclusive on the day of inclusion
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT00255021
Start Date
December 1 2005
End Date
January 1 2009
Last Update
April 16 2012
Active Locations (1)
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1
Bangkok, Thailand