An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants.
An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants.
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 cell disease when administred at 2,3, and 4 months of age.
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.