NCT00616421

Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,907 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM	1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
BIOLOGICAL	MenACWY-CRM	2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age
BIOLOGICAL	Licensed meningococcal ACWY vaccine	1 injection of the licensed meningococcal ACWY was administered intramuscularly

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-04-01
• Completion: 2009-10-01
• First posted: 2008-02-15
• Last updated: 2016-02-15
• Results posted: 2011-06-09

Locations

68 sites across 2 countries: United States, Canada