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

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NCT00368186

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Paris, , 75019 France
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
57-112 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Infants with neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by
hemoglobin electrophoresis.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00368186
Pfizer
Terminated
Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.

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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
Intervention Model: Single Group Assignment
Masking: None (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.
Sexes Eligible for Study: All
57 Days to 112 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00368186
0877X-100722
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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