NCT01434680

Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 992 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

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.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	MenC-CRM LIQ	One dose of MenC-CRM vaccine, liquid formulation
BIOLOGICAL	MenC-CRM ROS	One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
BIOLOGICAL	MenC-CRM EMV	One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-09-15
• Last updated: 2017-04-25
• Results posted: 2014-03-26

Locations

11 sites across 1 country: Poland