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

Phase 4

Completed

• Conditions: Meningococcal Infections; Meningitis; Meningococcal Meningitis
• Interventions: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

• Registration Number: NCT02864927
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Study Timeline

• Study Start: 2016-07-21
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Primary Completion: 2019-06-12
• Study Completion: 2019-06-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1311

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menactra Group 1	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Participants aged 9 to 23 months will receive 2 doses of Menactra
Menactra Group 2	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Participants aged 2 to 55 years will receive 1 dose of Menactra

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Solicited Injection-Site Reactions and Systemic Reactions Following Vaccination with Menactra®	Day 0 up to Day 30 post-vaccination	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
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra®	Day 0 up to Day 30 post-vaccination