At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,610 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 STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS>=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 1,610 participants across 75 sites in 4 countries.
Detailed Summary
This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Vaccine
CountriesCzechia, Finland, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartApr 2017
First PostedMay 2017
Primary CompletionOct 2022
TodayJul 2026
First PostedMay 1, 2017
Enrollment StartApr 24, 2017
Primary CompletionOct 25, 2022
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.2 years ago
Interventions
MenABCWYbiological
N meningitidis group A, B, C, W, and Y vaccine
Salinebiological
Placebo
rLP2086biological
Bivalent recombinant lipoprotein 2086 vaccine
MenACWY-CRMbiological
meningococcal group A, C, W-135, and Y conjugate vaccine