A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
2 other identifiers
interventional
801
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2000
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedResults Posted
Study results publicly available
January 29, 2010
CompletedJuly 28, 2015
July 1, 2015
1.7 years
September 24, 2009
December 23, 2009
July 16, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Varicella
6 weeks Postvaccination
Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Measles
6 weeks Postvaccination
Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Mumps
6 weeks Postvaccination
Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Rubella
6 weeks Postvaccination
Study Arms (3)
1
EXPERIMENTALProQuad + Placebo
2
ACTIVE COMPARATORM-M-R II + Placebo
3
ACTIVE COMPARATORM-M-R II + Varivax
Interventions
A Single 0.5 mL subcutaneous injection at Day 1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Reisinger KS, Brown ML, Xu J, Sullivan BJ, Marshall GS, Nauert B, Matson DO, Silas PE, Schodel F, Gress JO, Kuter BJ; Protocol 014 Study Group for ProQuad. A combination measles, mumps, rubella, and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy children vaccinated previously with M-M-RII and Varivax. Pediatrics. 2006 Feb;117(2):265-72. doi: 10.1542/peds.2005-0092.
PMID: 16452343RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
GMTs (adjusted for prevaccination titer, study center, and primary vaccination history status) have been reported in the literature. One subject received diluent only at visit 1 and was excluded from all immunogenicity/safety summaries.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2009
First Posted
September 28, 2009
Study Start
August 1, 2000
Primary Completion
May 1, 2002
Study Completion
May 1, 2003
Last Updated
July 28, 2015
Results First Posted
January 29, 2010
Record last verified: 2015-07