CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,907 enrolled
Drug / intervention
MenACWY-CRM +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.

Search/NCT00616421
NCT00616421Phase 3Completed

A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age

Novartis Vaccines·interventional·Posted Feb 15, 2008·Updated Feb 15, 2016

In Brief

A Phase 3 clinical trial evaluating MenACWY-CRM and Licensed meningococcal ACWY vaccine for Meningococcal Infections. Completed, enrolled 2,907 participants across 68 sites in 2 countries.

Detailed Summary

To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 15, 2008
Enrollment StartMar 1, 2008
Primary CompletionApr 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.4 years ago

Interventions

MenACWY-CRMbiological

1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly

MenACWY-CRMbiological

2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age

Licensed meningococcal ACWY vaccinebiological

1 injection of the licensed meningococcal ACWY was administered intramuscularly