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

NCT02864927 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1311

Last updated 2022-04-25

No results posted yet for this study

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.

Conditions

  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-21
Primary Completion
2019-06-12
Completion
2019-06-12

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02864927 on ClinicalTrials.gov