NCT01766206

Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea

A Multicenter Post Marketing Surveillance Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ACWY Conjugate Vaccine(MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects From 2 Months to 55 Years of Age in the Republic of South Korea.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,948 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Months – 55 Years
• Healthy volunteers: Accepted

Summary

A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM (Menveo)	One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.

Timeline

• Start date: 2013-03-15
• Primary completion: 2018-01-22
• Completion: 2018-01-22
• First posted: 2013-01-11
• Last updated: 2018-09-21
• Results posted: 2018-09-21

Locations

54 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study