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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00092430
Other study ID # V221-016
Secondary ID 2004_076
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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