At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 715 enrolled
Drug / intervention
MenACWY-CRMbiological
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 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.
In Brief
A Phase 3 clinical trial evaluating MenACWY-CRM for Meningococcal Disease and Infections, Meningococcal. Completed, enrolled 715 participants across 19 sites.
Detailed Summary
This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease, Infections, Meningococcal
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartOct 2012
Primary CompletionJul 2013
Study CompletionMay 2014
TodayJul 2026
First PostedSep 11, 2012
Enrollment StartOct 7, 2012
Primary CompletionJul 2, 2013
Study CompletionMay 30, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.8 years ago
Interventions
MenACWY-CRMbiological
The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm