Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
NCT00918580
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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 <18 years.
- 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.
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Pneumococcal Conjugate VaccineStudy Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
| Condition ICMJE | Pneumococcal Conjugate Vaccine | |||
| Intervention ICMJE | Biological: 13-valent Pneumoccocal Conjugate Vaccine
2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months. Other Name: 13vPnC | |||
| Study Arms ICMJE | Experimental: 1
Intervention: Biological: 13-valent Pneumoccocal Conjugate Vaccine | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 158 | |||
| Original Estimated Enrollment ICMJE | 200 | |||
| Actual Study Completion Date ICMJE | March 2013 | |||
| Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 6 Years to 17 Years (Child) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Egypt, France, Italy, Lebanon, Saudi Arabia, United Kingdom, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00918580 | |||
| Other Study ID Numbers ICMJE | 6096A1-3014 B1851013 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||