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Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

Infections, Meningococcal Clinical Trial

Official title:
A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults

Clinical Trial Summary

The purpose of this study was to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety were evaluated in the study.

Clinical Trial Description

As per the feedback from the Center for Biologics Evaluation and Research (CBER), the scope of this post-marketing commitment study was extended to demonstrate the effectiveness, immunogenicity, and safety of GSK's investigational combined meningococcal ABCWY vaccine along with the rMenB+OMV NZ vaccine. Note that the rMenB+OMV and MenACWY vaccines provided to the MenB_0_2_6, MenB_0_6 group, and MenACWY group, respectively, at day 211 were only as part of the standard care of treatment and to maintain blinding. These vaccination schedules were not considered for any endpoint evaluations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04502693
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date August 14, 2020
Completion date September 13, 2022
View Details
See also
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