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Booster and Catch-up Vaccination With Vaccine GSK1024850A

2014-08-27 03:17:19 | BioPortfolio

Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of pneumococcal vaccine GSK1024850A administered either at 9-12 months or 15-18 months of age in children primed in primary study NCT00814710.

This study also aims to assess the persistence of antibodies induced following primary vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to booster vaccination and following vaccination in the present study at approximately 24 months of age.

The study is also designed to evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.

Description

The study is randomized for primed subjects and non-randomized for unprimed subjects.

Study Design

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

Conditions

Pneumococcal Disease

Intervention

Pneumococcal vaccine GSK1024850A, Pneumococcal vaccine GSK1024850A

Location

GSK Investigational Site
Kolkata
India
700073

Status

Recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:19-0400

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Medical and Biotech [MESH] Definitions

A pneumococcal vaccine which 7 pneumococcal serotypes (6B, 14, 19F, 23F, 18C, 4, 9V), each conjugated individually to the outer membrane protein complex of NEISSERIA MENINGITIDIS.

A febrile disease caused by STREPTOCOCCUS PNEUMONIAE.

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