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

NCT02864927

CompletedPhase 4

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Meningitis, Meningococcal Meningitis, Meningococcal Infections

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

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 9 Months to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.
Locations (1)
  • Seoul, South Korea