Back to resultsImmunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.
Primary Purpose
Pneumococcal Infections
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Pneumo 23
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Antibody responses to pneumococcal capsular polysaccharides antigens contained in PCV7 vaccine; local and systemic reactions.
Secondary Outcome Measures
Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.
Full Information
NCT ID
NCT00368186
First Posted
August 21, 2006
Last Updated
August 23, 2006
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00368186
Brief Title
Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.
Official Title
An Open, Multicenter Clinical Trial to Investigate the Immunogenicity and Safety of the Pneumococcal 7-Valent Conjugate Vaccine (PREVENAR) in Sickle Cell Disease Infants.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Terminated
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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 cell disease when administred at 2,3, and 4 months of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Pneumo 23
Primary Outcome Measure Information:
Title
Antibody responses to pneumococcal capsular polysaccharides antigens contained in PCV7 vaccine; local and systemic reactions.
Secondary Outcome Measure Information:
Title
Opsonophagocytic activity; S. pneumoniae nasopharyngeal carriage.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
57 Days
Maximum Age & Unit of Time
112 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.
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