A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
Primary Purpose
Measles, Mumps, Rubella
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
Comparator: M-M-R II
Comparator: Varivax
Comparator: Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Measles
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
ProQuad + Placebo
M-M-R II + Placebo
M-M-R II + Varivax
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00985166
First Posted
September 24, 2009
Last Updated
July 16, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00985166
Brief Title
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
Official Title
Administration of Frozen Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine to Healthy Children at 4 to 6 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles, Mumps, Rubella, Varicella
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
801 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ProQuad + Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
M-M-R II + Placebo
Arm Title
3
Arm Type
Active Comparator
Arm Description
M-M-R II + Varivax
Intervention Type
Biological
Intervention Name(s)
ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
Other Intervention Name(s)
ProQuad
Intervention Description
A Single 0.5 mL subcutaneous injection at Day 1
Intervention Type
Biological
Intervention Name(s)
Comparator: M-M-R II
Intervention Description
A Single 0.5 mL subcutaneous injection at Day 1
Intervention Type
Biological
Intervention Name(s)
Comparator: Varivax
Intervention Description
A Single 0.5 mL subcutaneous injection at Day 1
Intervention Type
Biological
Intervention Name(s)
Comparator: Placebo
Intervention Description
A Single 0.5 mL subcutaneous placebo injection at Day 1
Primary Outcome Measure Information:
Title
Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Time Frame
6 weeks Postvaccination
Title
Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to Measles
Time Frame
6 weeks Postvaccination
Title
Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to Mumps
Time Frame
6 weeks Postvaccination
Title
Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Description
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Time Frame
6 weeks Postvaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16452343
Citation
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. Erratum In: Pediatrics. 2006 Jun;117(6):2338.
Results Reference
result
Learn more about this trial
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
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