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Study to Assess the Immunogenicity and Safety of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age

2020-03-27 03:25:34 | BioPortfolio

Summary

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

Description

As per the recommendation from Center for Biologics Evaluation and Research (CBER) the study has been amended to include a new "agar-overlay" serum bactericidal assay using human serum complement (hSBA). Additional changes include validation of the MenB manual to measure immunogenicity of the meningococcal group B vaccine, a modification in the definition of 4-fold increase in post-vaccination hSBA titer definition when the pre-vaccination titer is below the limit of detection, and a modification in the population set to be used for safety analysis wherein the exposed set is to be used for all safety analyses.

Study Design

Conditions

Infections, Meningococcal

Intervention

Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ), Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid), Placebo

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-27T03:25:34-0400

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Medical and Biotech [MESH] Definitions

Infections with bacteria of the species NEISSERIA MENINGITIDIS.

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.

Vaccines or candidate vaccines used to prevent infection with NEISSERIA MENINGITIDIS.

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.

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