A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Measles; Mumps; Rubella; Varicella
Intervention: ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) (Biological); Comparator: M-M-R II (Biological); Comparator: Varivax (Biological); Comparator: Placebo (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
The study was conducted to determine if ProQuad may be used in place of the second dose of
M-M-R II routinely given to children 4 to 6 years old who were previously immunized with
M-M-R II and Varivax.
Clinical Details
Official title: Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean TiterAntibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Eligibility
Minimum age: 4 Years.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- In good health
- Received primary dose of M-M-R II at less than or equal to 12 months of age
- Received primary dose of Varivax at less than or equal to 12 months of age
- Negative history of varicella, zoster, measles, mumps, and rubella
Exclusion Criteria:
- history of receiving more than once dose of M-M-R II or Varivax
- Any immune impairment or deficiency
- Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to
vaccination
- Vaccination with an inactive vaccine with in the past 14 days
- Vaccination with a live vaccine within the past 30 days
- Receipt of immune globulin, or blood product in the past 5 months
Locations and Contacts
Additional Information
MedWatch - FDA maintained medical product safety Information Merck: Patient & Caregiver U.S. Product Web Site
Starting date: August 2000
Last updated: July 16, 2015
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