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Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali

2014-08-27 03:19:00 | BioPortfolio

Summary

The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).

Study Design

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

Conditions

Pneumococcal Disease

Intervention

Pneumococcal vaccine GSK1024850A

Location

GSK Investigational Site
Bamako
Mali

Status

Active, not recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:00-0400

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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.

Infections with bacteria of the species STREPTOCOCCUS PNEUMONIAE.

Vaccines or candidate vaccines used to prevent infections with STREPTOCOCCUS PNEUMONIAE.

An acute purulent infection of the meninges and subarachnoid space caused by Streptococcus pneumoniae, most prevalent in children and adults over the age of 60. This illness may be associated with OTITIS MEDIA; MASTOIDITIS; SINUSITIS; RESPIRATORY TRACT INFECTIONS; sickle cell disease (ANEMIA, SICKLE CELL); skull fractures; and other disorders. Clinical manifestations include FEVER; HEADACHE; neck stiffness; and somnolence followed by SEIZURES; focal neurologic deficits (notably DEAFNESS); and COMA. (From Miller et al., Merritt's Textbook of Neurology, 9th ed, p111)

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