NCT00329849

Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Accepted

Summary

Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal ACWY-CRM conjugate vaccine	MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.
BIOLOGICAL	Meningococcal ACWY-PS polysaccharide vaccine	MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2006-05-25
• Last updated: 2018-10-09
• Results posted: 2013-11-05

Locations

3 sites across 1 country: Argentina