Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00918580
First received: June 9, 2009
Last updated: April 8, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumococcal Conjugate Vaccine |
Biological: 13-valent Pneumoccocal Conjugate Vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
sickle cell disease
MedlinePlus related topics:
Sickle Cell Anemia
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The immune response as measured by fold rise in serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMC). [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The acceptability of the safety profile as measured by the incidence rates of injection site reactions, systemic events, and adverse events (AEs). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 158 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: 13-valent Pneumoccocal Conjugate Vaccine
2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
Other Name: 13vPnC
|
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918580
Locations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40202-3830 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Bronx, New York, United States, 10467 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37232 | |
| Egypt | |
| Pfizer Investigational Site | |
| Cairo, Egypt, 11361 | |
| Pfizer Investigational Site | |
| Cairo, Egypt, 11511 | |
| France | |
| Pfizer Investigational Site | |
| Paris, France, 75015 | |
| Italy | |
| Pfizer Investigational Site | |
| Orbassano (TO), Italy, 10043 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00165 | |
| Lebanon | |
| Pfizer Investigational Site | |
| Beirut, Lebanon | |
| Pfizer Investigational Site | |
| Beirut, Lebanon, 2833-7401 | |
| Saudi Arabia | |
| Pfizer Investigational Site | |
| Riyadh, Saudi, Saudi Arabia | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Manchester, Cheshire, United Kingdom, M27 4HA | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE5 9RS | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE1 9RT | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE1 7RH | |
| Pfizer Investigational Site | |
| London, United Kingdom, SW17 0RE | |
| Pfizer Investigational Site | |
| London, United Kingdom, E1 1BB | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00918580 History of Changes |
| Other Study ID Numbers: | 6096A1-3014, B1851013 |
| Study First Received: | June 9, 2009 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 16, 2013