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Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine

2014-08-27 03:32:37 | BioPortfolio

Summary

This protocol posting deals with objectives & outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).

Description

This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). No study vaccines will be administered within this study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Diseases Caused by Streptococcus Pneumoniae and Haemophilus Influenzae

Intervention

GSK1024805A, Prevenar

Location

GSK Investigational Site
Bydgoszcz
Poland
85-021

Status

Active, not recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:37-0400

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Medical and Biotech [MESH] Definitions

Inflammation of the NASAL MUCOSA in the FRONTAL SINUS. In many cases, it is caused by an infection of the bacteria STREPTOCOCCUS PNEUMONIAE or HAEMOPHILUS INFLUENZAE.

Inflammation of the NASAL MUCOSA in the MAXILLARY SINUS. In many cases, it is caused by an infection of the bacteria HAEMOPHILUS INFLUENZAE; STREPTOCOCCUS PNEUMONIAE; or STAPHYLOCOCCUS AUREUS.

A type of H. influenzae isolated most frequently from biotype I. Prior to vaccine availability, it was a leading cause of childhood meningitis.

A febrile disease caused by STREPTOCOCCUS PNEUMONIAE.

A species of HAEMOPHILUS found on the mucous membranes of humans and a variety of animals. The species is further divided into biotypes I through VIII.

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