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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Meningitis

Meningococcal Meningitis

Meningococcal Infections

Treatments

Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02864927

U1111-1174-4708 (Other Identifier)

MTA79

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,311 patients

Sex

All

Ages

9 months to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Informed consent form signed by the subject (for subjects from 19 to 55 years of age) or the parent(s) or other legal representative (for subjects from 9 months to 18 years of age)
Receipt of one dose of Menactra® (on the day of inclusion) according to approved local product insert paper .

Exclusion criteria

Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure
Subjects who already participated in this study.