NCT01062061

Re-examination Study For Varivax (V210-059 AM2)

Re-examination Study for General Vaccine Use to Assess the Safety Profile of Varivax in Usual Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 754 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

Summary

This survey is conducted for preparing application materials for re-examination under the Korean Pharmaceutical Affairs Laws and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of VARIVAX through collecting the safety information according to the Re-examination Regulation for New Drugs.

Detailed description

This post-marketing survey was conducted in the usual routine practice and the investigator enrolled participants vaccinated with VARIVAX continuously after study start. The purpose of the study was to assess the occurrence of adverse events and to identify factors that may affect the safety of the vaccine under real-life, post-marketing conditions. No hypothesis testing was conducted in this survey.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	VARIVAX™	Attenuated live varicella vaccine

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-02-04
• Last updated: 2015-09-04
• Results posted: 2013-07-03