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
Verified date | November 2019 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
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
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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