CompletedPhase 4

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

South Korea1,311 participantsStarted 2016-07-21

Plain-language 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.

Who can participate

Age range9 Months – 55 Years

SexALL

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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.

What they're measuring

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

Timeframe: Day 0 up to Day 30 post-vaccination

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

Timeframe: Day 0 up to Day 30 post-vaccination

Trial details

NCT IDNCT02864927

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-12

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