NCT01274897

A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea

A Phase 3, Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 11 to 55 Years of Age in Korea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 11 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Novartis MenACWY-CRM	All subjects had blood drawn at Day 1 and Day 29.
BIOLOGICAL	Saline Placebo	All subjects had blood drawn at Day 1 and Day 29.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-01-12
• Last updated: 2012-10-16
• Results posted: 2012-10-16

Locations

8 sites across 1 country: South Korea