At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,431 enrolled
Drug / intervention
MenABCWY +3 morebiological
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.
A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
In Brief
A Phase 3 clinical trial evaluating MenABCWY, Saline, and 2 other interventions for Meningococcal Vaccine. Completed, enrolled 2,431 participants across 78 sites in 5 countries.
Detailed Summary
The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to \<26 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Vaccine
CountriesCzechia, Denmark, Hungary, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
Enrollment StartJun 2020
First PostedJun 2020
Primary CompletionJul 2022
TodayJul 2026
First PostedJun 19, 2020
Enrollment StartJun 17, 2020
Primary CompletionJul 24, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.0 years ago
Interventions
MenABCWYbiological
N meningitidis groups A, B, C, W, and Y vaccine
Salinebiological
Placebo
Trumenbabiological
Bivalent recombinant lipoprotein 2086 vaccine
MenACWY-CRMbiological
Meningococcal group A, C, W-135, and Y conjugate vaccine