CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 754 enrolled
Drug / intervention
VARIVAX™biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01062061
NCT01062061N/ACompleted

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

Merck Sharp & Dohme LLC·observational·Posted Feb 4, 2010·Updated Sep 4, 2015

In Brief

An observational study evaluating VARIVAX™ for Varicella. Completed, enrolled 754 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsVaricella
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 4, 2010
Enrollment StartJun 1, 2007
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.4 years ago

Interventions

VARIVAX™biological

Attenuated live varicella vaccine