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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02864927
Other study ID # MTA79
Secondary ID U1111-1174-4708
Status Completed
Phase Phase 4
First received
Last updated
Start date July 21, 2016
Est. completion date June 12, 2019

Study information

Verified date April 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1311
Est. completion date June 12, 2019
Est. primary completion date June 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Months to 55 Years
Eligibility 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


Intervention

Biological:
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular. 2 doses 3 months apart
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra® Day 0 up to Day 30 post-vaccination
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