ProQuad Dose Selection Study (V221-011)(COMPLETED)
A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections
2 other identifiers
interventional
1,551
0 countries
N/A
Brief Summary
A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 1999
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 29, 2009
CompletedResults Posted
Study results publicly available
February 15, 2010
CompletedApril 10, 2015
March 1, 2015
1 year
September 25, 2009
January 25, 2010
March 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \<1.25 gpELISA units
6 weeks postvaccination
Secondary Outcomes (8)
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
6 weeks postvaccination
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
6 weeks Postvaccination
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
6 weeks Postvaccination
Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
6 weeks Postvaccination Visit 1 or Visit 2
Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)
6 weeks Postvaccination
- +3 more secondary outcomes
Study Arms (4)
1
EXPERIMENTALProQuad (low dose)
2
EXPERIMENTALProQuad (middle dose)
3
EXPERIMENTALProQuad (high dose)
4
ACTIVE COMPARATORM-M-R II + PUVV
Interventions
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
Eligibility Criteria
You may qualify if:
- In good health
- Negative clinical history of measles, mumps, rubella, varicella, and zoster
You may not qualify if:
- Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
- 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
- Immune globulin or any blood product administered in the past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schodel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):670-5. doi: 10.1097/01.inf.0000172901.29621.e9.
PMID: 16094218RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Seven (7) participants received unknown clinical material and 1 participant received diluent only; they were considered to be protocol violators and weren't included in the efficacy/safety analyses.
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 2
- 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 25, 2009
First Posted
September 29, 2009
Study Start
April 1, 1999
Primary Completion
April 1, 2000
Study Completion
September 1, 2000
Last Updated
April 10, 2015
Results First Posted
February 15, 2010
Record last verified: 2015-03