CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,250 enrolled
Drug / intervention
MenABCWY vaccine +3 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/NCT04707391
NCT04707391Phase 3Completed
CompareCT.gov

A Phase IIIB, Randomized, Controlled, Observer-blind Study to Evaluate Safety and Immunogenicity of GSK's Meningococcal ABCWY Vaccine When Administered in Healthy Adolescents and Adults, Previously Primed With Meningococcal ACWY Vaccine

GlaxoSmithKline·interventional·Posted Jan 13, 2021·Updated Jul 3, 2024

In Brief

A Phase 3 clinical trial evaluating MenABCWY vaccine, Placebo, and 2 other interventions for Meningitis, Meningococcal. Completed, enrolled 1,250 participants across 69 sites in 4 countries.

Detailed Summary

The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal
CountriesArgentina, Australia, Canada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJan 13, 2021
Enrollment StartJan 25, 2021
Primary CompletionMay 3, 2023
Study CompletionSep 29, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.5 years ago

Interventions

MenABCWY vaccinecombination

2 doses of MenABCWY vaccine administered intramuscularly on Day 1 and Day 181 to participants in ABCWY group.

Placebocombination

1 dose of placebo administered intramuscularly on Day 211 to participants in ABCWY group

MenACWY vaccinebiological

1 dose of MenACWY vaccine administered intramuscularly on Day 1 to participants in ACWY group

MenB vaccinecombination

2 doses of MenB vaccine administered intramuscularly on Day 181 and Day 211 to participants in ACWY group. MenB vaccine is a non-investigational medical product (NIMP) in this study and is administered only in compliance with standard of care.