NCT00474487

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,831 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Meningococcal Meningitis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal ACWY Polysaccharide Vaccine	One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
BIOLOGICAL	MenACWY CRM (19 to 55 years)	One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.
BIOLOGICAL	Meningococcal ACWY Conjugate Vaccine	One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.
BIOLOGICAL	Novartis MenACWY Vaccine (56 to 65 Years)	One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-08-01
• Completion: 2008-02-01
• First posted: 2007-05-17
• Last updated: 2014-04-21
• Results posted: 2010-08-04

Locations

2 sites across 2 countries: Argentina, Colombia