NCT04318548

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

A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 945 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 16 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)	1 dose of rMenB+OMV administered intramuscularly at day 1 and 61 to participants in MenB+MenACWY group and MenB group and as 1 dose at day 91 to participants in MenACWY group.
BIOLOGICAL	Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)	1 dose of MenACWY administered intramuscularly at day 1 to participants in MenB+MenACWY group and MenACWY group, 1 dose at day 91 to participants for MenB group.
COMBINATION_PRODUCT	Placebo	1 dose of Placebo administered intramuscularly at 1 to participants in MenB group and MenACWY group and as 1 dose at day 91 to participants in MenB+MenACWY group.

Timeline

• Start date: 2020-08-25
• Primary completion: 2023-11-21
• Completion: 2023-11-21
• First posted: 2020-03-24
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

53 sites across 2 countries: United States, Italy

Regulatory

• FDA-regulated drug study