Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00368186
First received: August 21, 2006
Last updated: August 23, 2006
Last verified: August 2006

August 21, 2006
August 23, 2006
May 2001
Not Provided
Antibody responses to pneumococcal capsular polysaccharides antigens contained in PCV7 vaccine; local and systemic reactions.
Same as current
Complete list of historical versions of study NCT00368186 on ClinicalTrials.gov Archive Site
Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine 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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Pneumococcal Infections
Biological: Pneumo 23
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
November 2002
Not Provided

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.

Both
57 Days to 112 Days
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00368186
0877X-100722
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP