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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Varicella

Treatments: Biological: VARIVAX™

Study type: Observational

Funder types: Industry

Identifiers

NCT01062061

2010_004 (Other Identifier)

V210-059

Details and patient eligibility

About

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.

Full 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.

Enrollment: 754 patients

Sex: All

Ages: 12+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must be vaccinated with VARIVAX as a standard of care

Exclusion criteria

• Participants who have been previously vaccinated with VARIVAX
• Contraindication with VARIVAX

Trial design

754 participants in 1 patient group

VARIVAX

Description:

Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.

Treatment:

Biological: VARIVAX™