NCT01642589

Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea

Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Versus Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) in Subjects 11 to 55 Years of Age in South Korea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 11 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in support of registration of the vaccine in South Korea. Primary Objective: * To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y and W-135, 28 days after a single dose of Menactra®. Secondary objectives: * To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine * To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine. * To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers before and 28 days after a single dose of Menactra® or Adacel® vaccine.

Detailed description

All participants will receive a single dose of vaccine, and will be assessed for immunogenicity at baseline (pre-vaccination) and at 28 days post-vaccination. Safety data, including serious adverse events (SAEs) will be collected for Day 0 through Day 28 post-vaccination.

Conditions

• Meningitis
• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)	0.5 mL, Intramuscular
BIOLOGICAL	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed	0.5 mL, Intramuscular

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-01-01
• Completion: 2013-06-01
• First posted: 2012-07-17
• Last updated: 2013-12-03
• Results posted: 2013-12-03

Locations

7 sites across 1 country: South Korea