Safety Study of a Refrigerator-stable Formulation of VARIVAX®

Phase 4 Completed 500 enrolled Merck Sharp & Dohme LLC

RandomizedCrossoverDouble-blind

Summary

Primary objective: To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination. Secondary objectives: NA

Timeline

Start: 2004-12
Primary completion: 2005-09
Completion: 2005-09

Publications

Ferrera G, Gajdos V, Thomas S, Tran C, Fiquet A. Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study. Hum Vaccin. 2009 Jul;5(7):455-60. doi: 10.4161/hv.8269. Epub 2009 Jul 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	M-M-R II	Vaccine	—	—
Subject	Varivax	Vaccine	—	Subcutaneous

Safety Study of a Refrigerator-stable Formulation of VARIVAX®

Summary

Timeline

Publications

Drugs

Indications