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

Primary Purpose

Meningitis, Meningococcal Meningitis, Meningococcal Infections

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Meningitis focused on measuring Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine

Eligibility Criteria

9 Months - 55 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Menactra Group 1

Menactra Group 2

Arm Description

Participants aged 9 to 23 months will receive 2 doses of Menactra

Participants aged 2 to 55 years will receive 1 dose of Menactra

Outcomes

Primary Outcome Measures

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

Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra®

Secondary Outcome Measures

Full Information

NCT ID

NCT02864927

First Posted

August 5, 2016

Last Updated

April 21, 2022

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT02864927

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

July 21, 2016 (Actual)

Primary Completion Date

June 12, 2019 (Actual)

Study Completion Date

June 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Meningococcal Meningitis, Meningococcal Infections

Keywords

Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1311 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Menactra Group 1

Arm Type

Experimental

Arm Description

Participants aged 9 to 23 months will receive 2 doses of Menactra

Arm Title

Menactra Group 2

Arm Type

Experimental

Arm Description

Participants aged 2 to 55 years will receive 1 dose of Menactra

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

Menactra®

Intervention Description

0.5 mL, Intramuscular. 2 doses 3 months apart

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

Menactra®

Intervention Description

0.5 mL, Intramuscular

Primary Outcome Measure Information:

Title

Number of Participants Reporting Solicited Injection-Site Reactions and Systemic Reactions Following Vaccination with Menactra®

Description

Time Frame

Day 0 up to Day 30 post-vaccination

Title

Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra®

Time Frame

Day 0 up to Day 30 post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Months

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi Pasteur, a Sanofi Company

Official's Role

Study Director

Facility Information:

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

33439463

Citation

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(R)) 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.

Results Reference

derived

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

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