CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,831 enrolled
Drug / intervention
Meningococcal ACWY Polysaccharide Vaccine +3 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/NCT00474487
NCT00474487Phase 3Completed

A Phase 3, Multi-center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.

Novartis Vaccines·interventional·Posted May 17, 2007·Updated Apr 21, 2014

In Brief

A Phase 3 clinical trial evaluating Meningococcal ACWY Polysaccharide Vaccine, MenACWY CRM (19 to 55 years), and 2 other interventions for Meningococcal Meningitis and Meningococcal Infections. Completed, enrolled 2,831 participants across 2 sites in 2 countries.

Detailed Summary

This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Colombia
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 17, 2007
Enrollment StartMay 1, 2007
Primary CompletionAug 1, 2007
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 19.1 years ago

Interventions

Meningococcal ACWY Polysaccharide Vaccinebiological

One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.

MenACWY CRM (19 to 55 years)biological

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.

Meningococcal ACWY Conjugate Vaccinebiological

One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.

Novartis MenACWY Vaccine (56 to 65 Years)biological

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.