NCT00918580

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumococcal Conjugate Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	13-valent Pneumoccocal Conjugate Vaccine	2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-06-11
• Last updated: 2014-04-21
• Results posted: 2014-04-21

Locations

19 sites across 7 countries: United States, Egypt, France, Italy, Lebanon, Saudi Arabia, United Kingdom