CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 992 enrolled
Drug / intervention
MenC-CRM LIQ +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/NCT01434680
NCT01434680Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of the New Liquid Formulation of Novartis Meningococcal C Conjugate Vaccine and of the Novartis Lyophilized Meningococcal C Conjugate Vaccine Manufactured at Two Different Sites, in Healthy Toddlers

Novartis·interventional·Posted Sep 15, 2011·Updated Apr 25, 2017

In Brief

A Phase 2 clinical trial evaluating MenC-CRM LIQ, MenC-CRM ROS, and 1 other intervention for Meningococcal Disease and Meningococcal Meningitis. Completed, enrolled 992 participants across 11 sites.

Detailed Summary

The study was to evaluate the safety and and immune response of each of three lots of Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy Toddlers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Disease, Meningococcal Meningitis
CountriesPoland
CollaboratorsNovartis Vaccines

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2011
Enrollment StartSep 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.8 years ago

Interventions

MenC-CRM LIQbiological

One dose of MenC-CRM vaccine, liquid formulation

MenC-CRM ROSbiological

One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.

MenC-CRM EMVbiological

One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.