NCT00581620

Study Evaluating Prevenar Immunogenicity in High Risk Children

To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 2 Months – 9 Years
• Healthy volunteers: Not accepted

Summary

To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.

Detailed description

This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months

Conditions

• Vaccines, Pneumococcal Conjugate Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	pneumococcus conjugate vaccine	Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.

Timeline

• Start date: 2002-11-01
• Completion: 2007-09-01
• First posted: 2007-12-27
• Last updated: 2007-12-27