At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 450 enrolled
Drug / intervention
Novartis MenACWY-CRM +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 3, Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 11 to 55 Years of Age in Korea
In Brief
A Phase 3 clinical trial evaluating Novartis MenACWY-CRM and Saline Placebo for Meningococcal Disease and Meningococcal Meningitis. Completed, enrolled 450 participants across 8 sites.
Detailed Summary
This study is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease, Meningococcal Meningitis
CountriesSouth Korea
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedJan 2011
Primary CompletionMar 2011
TodayJul 2026
First PostedJan 12, 2011
Enrollment StartDec 1, 2010
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.5 years ago
Interventions
Novartis MenACWY-CRMbiological
All subjects had blood drawn at Day 1 and Day 29.
Saline Placebobiological
All subjects had blood drawn at Day 1 and Day 29.