NCT02864927

Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea

Postmarketing Surveillance Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in the Republic of Korea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,311 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation. Primary objective: * To describe the safety profile after 1 dose of Menactra® administered from 9 months to 55 years of age under standard health care practice.

Detailed description

Subjects aged 9 months through 55 years and who are given study vaccine during routine health-care visits will be enrolled in the study. They will be followed-up for up to Day 42 following vaccination. No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Conditions

• Meningitis
• Meningococcal Meningitis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	0.5 mL, Intramuscular. 2 doses 3 months apart
BIOLOGICAL	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2016-07-21
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2016-08-12
• Last updated: 2022-04-25

Locations

1 site across 1 country: South Korea