Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092430

Enrollment

1200

Registered

2004-09-27

Start date

2002-09-26

Completion date

2003-06-09

Last updated

2019-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles, Mumps, Rubella, Varicella

Brief summary

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.

Interventions

BIOLOGICALV221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Months to 23 Months

Healthy volunteers

Yes

Inclusion criteria

* Healthy children 12-23 months of age

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percent of patients demonstrating adequate antibody titers 6 weeks following administration	—

Secondary

Measure	Time frame
Geometric mean titers (GMT) 6 weeks post vaccination	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026