CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 945 enrolled
Drug / intervention
Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) +2 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04318548
NCT04318548Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Mar 24, 2020·Updated Mar 4, 2025

In Brief

A Phase 3 clinical trial evaluating Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ), Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid), and 1 other intervention for Infections, Meningococcal. Completed, enrolled 945 participants across 53 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesItaly, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 24, 2020
Enrollment StartAug 25, 2020
Primary CompletionNov 21, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.3 years ago

Interventions

Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)combination

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.

Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)biological

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.

Placebocombination

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.