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

Completed · Phase 3

Conditions studied: Pneumococcal Conjugate Vaccine

In brief

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.

Key facts

Study ID

NCT00918580

Run by

Pfizer

People needed

158

Starts

2009-11-01

Expected to finish

2013-03-01

Last updated by the study team

2014-04-21

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — The Bronx, New York, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — Cairo, Cairo Governorate, Egypt
• Pfizer Investigational Site — Cairo, Cairo Governorate, Egypt
• Pfizer Investigational Site — Paris, France
• Pfizer Investigational Site — Orbassano (TO), Italy
• Pfizer Investigational Site — Roma, Italy
• Pfizer Investigational Site — Beirut, Lebanon, Lebanon
• Pfizer Investigational Site — Beirut, Lebanon
• Pfizer Investigational Site — Riyadh, Saudi, Saudi Arabia
• Pfizer Investigational Site — Manchester, Cheshire, United Kingdom
• Pfizer Investigational Site — London, United Kingdom, United Kingdom
• Pfizer Investigational Site — London, United Kingdom
• Pfizer Investigational Site — London, United Kingdom
• Pfizer Investigational Site — London, United Kingdom
• Pfizer Investigational Site — London, United Kingdom

Full record on ClinicalTrials.gov

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