NCT00450437

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

A Phase 3, Multi-center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,539 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 11 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Meningococcal Infections
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY CRM	One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
BIOLOGICAL	Meningococcal ACWY Conjugate vaccine	One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-08-01
• Completion: 2008-01-01
• First posted: 2007-03-22
• Last updated: 2015-01-28
• Results posted: 2010-09-24

Locations

40 sites across 1 country: United States