At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 309 enrolled
Drug / intervention
MenABCWY +1 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 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE
In Brief
A Phase 2 clinical trial evaluating MenABCWY and Saline for Meningococcal Vaccine. Completed, enrolled 309 participants across 20 sites.
Detailed Summary
This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Vaccine
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartJun 2020
First PostedJun 2020
Primary CompletionJan 2024
TodayJul 2026
First PostedJun 19, 2020
Enrollment StartJun 17, 2020
Primary CompletionJan 5, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.0 years ago
Interventions
MenABCWYbiological
Neisseria meningitidis group A, B, C, W, and Y vaccine
Salinebiological
Placebo