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

Measles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092430
• Other study ID #: V221-016
• Secondary ID: 2004_076
• Status: Completed
• Phase: Phase 3
• Start date: September 26, 2002
• Est. completion date: June 9, 2003

Study information

• Verified date: November 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 9, 2003
• Est. primary completion date: June 9, 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 23 Months

Eligibility

Inclusion Criteria:

• Healthy children 12-23 months of age

Exclusion Criteria:

• Previously had measles, mumps, rubella, or varicella

• Compromised immune system

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Bernstein HH, Eves K, Campbell K, Black SB, Twiggs JD, Reisinger KS, Conti RM, Flodmark CE, Rombo L, Klopfer S, Schödel F, Hartzel J, Kuter BJ; Refrigerator-Stable Formulation Study Group for ProQuad. Comparison of the safety and immunogenicity of a refri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients demonstrating adequate antibody titers 6 weeks following administration
Secondary	Geometric mean titers (GMT) 6 weeks post vaccination