Study Evaluating Prevenar Immunogenicity in High Risk Children

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

Completed

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Key information

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Age range

2 month–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pneumococcus conjugate vaccine

Biological

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

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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Study completion: 2007
First posted: Dec 27, 2007
Registry last updated: Dec 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed