Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092430

Purpose

The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.

Condition	Intervention	Phase
Measles Mumps Rubella Varicella	Biological: V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks	Phase III

MedlinePlus related topics: Chickenpox Measles Mumps Rubella Shingles

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study
Official Title:	A Comparison of the Safety, Tolerability, and Immunogenicity of a Refrigerator-Stable Measles, Mumps, Rubella, and Varicella Combination Vaccine V221 (Refrigerated) Versus V221 (Frozen) in Healthy Children

Further study details as provided by Merck:

Primary Outcome Measures:

Percent of patients demonstrating adequate antibody titers 6 weeks following administration

Secondary Outcome Measures:

Geometric mean titers (GMT) 6 weeks post vaccination

Estimated Enrollment:	1200
Study Start Date:	September 2002
Study Completion Date:	May 2003

Eligibility

Ages Eligible for Study:	12 Months to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy children 12-23 months of age

Exclusion Criteria:

Previously had measles, mumps, rubella, or varicella
Compromised immune system

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092430

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_076
Study First Received:	September 22, 2004
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00092430
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Herpes Zoster
Mouth Diseases
Paramyxoviridae Infections
Measles
Chickenpox
Healthy
Rubella
Togaviridae Infections

Herpesviridae Infections
Virus Diseases
DNA Virus Infections
Chicken pox
Stomatognathic Diseases
Salivary Gland Diseases
Mumps

Additional relevant MeSH terms:

Rubivirus Infections
Parotid Diseases
RNA Virus Infections
Morbillivirus Infections

Rubulavirus Infections
Parotitis
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 16, 2009