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.

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

Study Overview

• Status: Completed
• Conditions: Vaccines, Pneumococcal Conjugate Vaccine
• Intervention / Treatment: Biological: pneumococcus conjugate vaccine

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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children between 2 months to 9 years old.
• Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
• No history of seizures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: G1; G1: HIV+	Biological: pneumococcus conjugate vaccine; Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
Active Comparator: G2; G2: Sicle Cell disease	Biological: pneumococcus conjugate vaccine; Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
Active Comparator: G3; G3: neprotic symdrome	Biological: pneumococcus conjugate vaccine; Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
Active Comparator: G4; G4: Chronic pulmonary disease	Biological: pneumococcus conjugate vaccine; Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate tolerability of Prevenar* in that population.	4 months

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): December 27, 2007

Study Record Updates

• Last Update Posted (Estimate): December 27, 2007
• Last Update Submitted That Met QC Criteria: December 21, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: pneumococcus conjugated vaccine
• Other Study ID Numbers: 0887X-100974