Status:
COMPLETED
Immunogenicity and Safety of Pentaxim in South African Infants
Lead Sponsor:
Sanofi
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
24+ years
Phase:
PHASE3
Brief Summary
The present clinical study will assess the immunogenicity and reactogenicity of Aventis Pasteur's DTacP-IPV// PRP\~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6,...
Eligibility Criteria
Inclusion
- Aged \< 24 hours on the day of inclusion
Exclusion
- At visit 01 (screening)
- Illness at a stage that could interfere with trial conduct or completion.
- Any vaccination preceding the trial participation (except Bacille Calmette-Guerin \[BCG\])
- Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
- Planned participation in another clinical trial during the present trial period
- Blood or blood-derived products received since birth.
- Mother known as seropositive to HIV or hepatitis B.
- Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of/current seizures at visit 02 (first study vaccination)
- Participation in another clinical trial preceding the first trial vaccination
- 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.
- Any vaccination preceding the first trial vaccination (except BCG)
- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.
- Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00254969
Start Date
October 1 2005
End Date
January 1 2010
Last Update
April 17 2012
Active Locations (1)
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1
Soweto, South Africa