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A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adults 18 to 40 Years of Age

NCT03652610 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 996

Last updated 2021-02-09

Study results available
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Summary

MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries.

The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine.

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A)

Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm

BIOLOGICAL

Licensed GSK MenACWY vaccine (Menveo)

Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-07
Primary Completion
2019-01-17
Completion
2019-06-11
FDA Drug
Yes

Countries

  • Australia
  • Belgium
  • Canada
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652610 on ClinicalTrials.gov