Status:
TERMINATED
Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
57-112 years
Phase:
PHASE4
Brief Summary
The primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age) with sickle cel...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin electrophoresis.
- Exclusion Criteria
- Previous immunization with pneumococcal-containing vaccines.
- History of pneumococcal invasive disease (meningitis, bacteremia, pneumonia).
- Known or suspected impairments of the immune system (including HIV infection) or recipients of immuno-suppressant agents.
- Other Exclusions apply.
Exclusion
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2002
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00368186
Start Date
May 1 2001
End Date
November 1 2002
Last Update
August 24 2006
Active Locations (1)
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1
Paris, France, 75019