CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,500 enrolled
Drug / intervention
Meningococcal ACWY-CRM conjugate vaccine +1 morebiological
Likely dose
Meningococcal ACWY-CRM conjugate vaccine 0.5 mLfrom 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/NCT00329849
NCT00329849Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age

Novartis Vaccines·interventional·Posted May 25, 2006·Updated Oct 9, 2018

In Brief

A Phase 3 clinical trial evaluating Meningococcal ACWY-CRM conjugate vaccine and Meningococcal ACWY-PS polysaccharide vaccine for Meningococcal Disease. Completed, enrolled 1,500 participants across 3 sites.

Detailed Summary

Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease
CountriesArgentina
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2006
Enrollment StartMay 1, 2006
Primary CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 20.1 years ago

Interventions

Meningococcal ACWY-CRM conjugate vaccinebiological

MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.

Meningococcal ACWY-PS polysaccharide vaccinebiological

MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.