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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease

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NCT00918580

Last updated on May 11, 2018
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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subject between the ages of >=6 to

- Diagnosis of SCD

- 23vPS vaccination at least 6 months prior to enrollment.

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

- Previous vaccination with pneumococcal conjugate vaccine.

- Previous reaction to any vaccine or vaccine-related component or contraindication to
vaccination with pneumococcal conjugate vaccine.

NCT00918580
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease

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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23vPS Vaccine
This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Conjugate Vaccine
Biological: 13-valent Pneumoccocal Conjugate Vaccine
2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
Other Name: 13vPnC
Experimental: 1
Intervention: Biological: 13-valent Pneumoccocal Conjugate Vaccine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
March 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subject between the ages of >=6 to <18 years.
  • Diagnosis of SCD
  • 23vPS vaccination at least 6 months prior to enrollment.

Exclusion Criteria:

  • Previous vaccination with pneumococcal conjugate vaccine.
  • Previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Egypt,   France,   Italy,   Lebanon,   Saudi Arabia,   United Kingdom,   United States
 
 
NCT00918580
6096A1-3014
B1851013
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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