At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 524 enrolled
Drug / intervention
MenACWY-CRM conjugate vaccine, adjuvanted +2 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 2, Randomized, Single-blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age
In Brief
A Phase 2 clinical trial evaluating MenACWY-CRM conjugate vaccine, adjuvanted, MenACWY-CRM conjugate vaccine, unadjuvanted, and 1 other intervention for Prevention of Meningococcal Disease. Completed, enrolled 524 participants across 3 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevention of Meningococcal Disease
CountriesUnited States
CollaboratorsNovartis
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2004
First PostedDec 2005
Primary CompletionMar 2006
TodayJul 2026
First PostedDec 6, 2005
Enrollment StartOct 1, 2004
Primary CompletionMar 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.6 years ago
Interventions
MenACWY-CRM conjugate vaccine, adjuvantedbiological
MenACWY-CRM conjugate vaccine, unadjuvantedbiological
MenACWY polysaccharide vaccinebiological