NCT03652610

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

Immunogenicity, Reactogenicity and Safety of Two Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) in Healthy Adults 18 to 40 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 996 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-09-07
• Primary completion: 2019-01-17
• Completion: 2019-06-11
• First posted: 2018-08-29
• Last updated: 2021-02-09
• Results posted: 2021-02-09

Locations

30 sites across 5 countries: Australia, Belgium, Canada, Germany, Italy

Regulatory

• FDA-regulated drug study