CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,657 enrolled
Drug / intervention
rMenB+OMV NZ vaccine +5 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/NCT04502693
NCT04502693Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Aug 6, 2020·Updated Mar 5, 2024

In Brief

A Phase 3 clinical trial evaluating rMenB+OMV NZ vaccine, Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY), and 4 other interventions for Infections, Meningococcal. Completed, enrolled 3,657 participants across 112 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesAustralia, Canada, Czechia, Estonia, Finland, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedAug 6, 2020
Enrollment StartAug 14, 2020
Primary CompletionSep 13, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.9 years ago

Interventions

rMenB+OMV NZ vaccinecombination

rMenB+OMV NZ vaccine was administered intramuscularly.

Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)biological

MenACWY vaccine was administered intramuscularly.

Placebocombination

Placebo was administered intramuscularly.

MenABCWY-1combination

Lot 1 of the MenABCWY vaccine was administered intramuscularly.

MenABCWY-2combination

Lot 2 of the MenABCWY vaccine was administered intramuscularly.

MenABCWY-3combination

Lot 3 of the MenABCWY vaccine was administered intramuscularly.