At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,539 enrolled
Drug / intervention
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 Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine
In Brief
A Phase 3 clinical trial evaluating MenACWY CRM and Meningococcal ACWY Conjugate vaccine for Meningococcal Infections and Meningococcal Meningitis. Completed, enrolled 3,539 participants across 40 sites.
Detailed Summary
This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Infections, Meningococcal Meningitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedMar 2007
Primary CompletionAug 2007
Study CompletionJan 2008
TodayJul 2026
First PostedMar 22, 2007
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 19.3 years ago
Interventions
MenACWY CRMbiological
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
Meningococcal ACWY Conjugate vaccinebiological
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.