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

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.

Study Overview

• Status: Completed
• Conditions: Meningitis; Meningococcal Infections; Meningococcal Meningitis
• Intervention / Treatment: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 1311
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menactra Group 1; Participants aged 9 to 23 months will receive 2 doses of Menactra	Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, Intramuscular; Other Names: Menactra®; Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, Intramuscular. 2 doses 3 months apart; Other Names: Menactra®
Experimental: Menactra Group 2; Participants aged 2 to 55 years will receive 1 dose of Menactra	Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, Intramuscular; Other Names: Menactra®; Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, Intramuscular. 2 doses 3 months apart; Other Names: Menactra®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Solicited Injection-Site Reactions and Systemic Reactions Following Vaccination with Menactra®	Solicited injection-site reactions: Tenderness/Pain, Erythema, and Swelling. Solicited systemic reactions: infants and toddlers (9 to 23 months) Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite and Irritability; Subjects aged 2 to 55 years, Fever (temperature), Headache, Malaise, and Myalgia	Day 0 up to Day 30 post-vaccination
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra®		Day 0 up to Day 30 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

General Publications

• Kim HS, Engel S, Neveu D, Thollot Y, Oster P, Yang K. Post-Marketing Surveillance Observational Study of Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (MenACWY-DT, MCV4/Menactra(®)) in the Republic of Korea, 2014-2019. Infect Dis Ther. 2021 Mar;10(1):399-409. doi: 10.1007/s40121-020-00393-4. Epub 2021 Jan 13.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2016
• Primary Completion (Actual): June 12, 2019
• Study Completion (Actual): June 12, 2019

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Menactra®; Meningococcal Vaccine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Meningococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: MTA79; U1111-1174-4708 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org