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.
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
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,311
0.5 mL, Intramuscular. 2 doses 3 months apart
0.5 mL, Intramuscular
Unnamed facility
Seoul, South Korea
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
Time frame: Day 0 up to Day 30 post-vaccination
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra®
Time frame: Day 0 up to Day 30 post-vaccination
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