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Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

2014-08-27 03:38:54 | BioPortfolio

Summary

This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.

Description

All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Study Design

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

Conditions

Meningococcal Serogroup A, C, W-135, Y Diseases

Intervention

Meningococcal vaccine 134612, Twinrix

Location

GSK Investigational Site
Aarhus N
Denmark
8200

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:54-0400

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Medical and Biotech [MESH] Definitions

Strains of Neisseria meningitidis responsible for most outbreaks of meningococcal disease in Western Europe and the United States in the first half of the 20th century. They continue to be a major cause of disease in Asia and Africa, and especially localized epidemics in Sub-Sahara Africa.

A species of gram-negative, aerobic BACTERIA. It is a commensal and pathogen only of humans, and can be carried asymptomatically in the NASOPHARYNX. When found in cerebrospinal fluid it is the causative agent of cerebrospinal meningitis (MENINGITIS, MENINGOCOCCAL). It is also found in venereal discharges and blood. There are at least 13 serogroups based on antigenic differences in the capsular polysaccharides; the ones causing most meningitis infections being A, B, C, Y, and W-135. Each serogroup can be further classified by serotype, serosubtype, and immunotype.

Infections with bacteria of the species NEISSERIA MENINGITIDIS.

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A set of variants within a species of microorganisms that are antigenically, closely related. With bacteria, a serogroup refers to a group that shares a common antigen.

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