Study Evaluating Prevenar Immunogenicity in High Risk Children

Wyeth is now a wholly owned subsidiary of Pfizer160 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

160

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Interventions

pneumococcus conjugate vaccineBIOLOGICAL

Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 9 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition

Time frame: 4 months

Secondary Outcomes

To evaluate tolerability of Prevenar* in that population.

Time frame: 4 months

Data from ClinicalTrials.gov

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