Study Stopped
Study terminated early because of insufficient enrollment before expiration date of the investigational vaccine lot
A Study of ProQuad™ in Healthy Children in Korea (V221-023)
A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children
2 other identifiers
interventional
30
0 countries
N/A
Brief Summary
This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant 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 below P25 for phase_3
Started Feb 2008
Shorter than P25 for phase_3
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
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 6, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedResults Posted
Study results publicly available
October 10, 2012
CompletedApril 12, 2017
March 1, 2017
3 months
February 6, 2009
September 7, 2012
March 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (\<255 mIU/mL) to measles at baseline
6 weeks postvaccination
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (\<10 units/mL) to mumps at baseline
6 weeks postvaccination
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (\<10 IU/mL) to rubella at baseline
6 weeks postvaccination
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (\<5 gpELISA units/mL) to VZV at baseline
6 weeks postvaccination
Secondary Outcomes (4)
Geometric Mean Titer of Measles Antibodies
6 weeks postvaccination
Geometric Mean Titer of Mumps Antibodies
6 weeks postvaccination
Geometric Mean Titer of Rubella Antibodies
6 weeks postvaccination
Geometric Mean Titer of VZV (gpELISA) Antibodies
6 weeks postvaccination
Other Outcomes (8)
Percentage of Participants With Measles-like Rash
Through 6 weeks postvaccination
Percentage of Participants With Varicella-like Rash
Through 6 weeks postvaccination
Percentage of Participants With Rubella-like Rash
Through 6 weeks postvaccination
- +5 more other outcomes
Study Arms (2)
ProQuad™
EXPERIMENTALM-M-R™ II and Varivax™
ACTIVE COMPARATORInterventions
Single administration of 0.5 mL subcutaneous injection
Single administration of 0.5 mL subcutaneous injection
Eligibility Criteria
You may qualify if:
- Subject is in good health
- Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster
You may not qualify if:
- Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
- Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
- Subject has a history of seizure disorder
- Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
- Subject has received an inactivated vaccine within the past 14 days
- Subject has received a live vaccine within the past 30 days
- Subject has received immune globulin within the past 5 months
- Subject has a recent history of fever (within the last 72 hours)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Formal testing of the study hypotheses was not possible because of low enrollment
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
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2009
First Posted
February 10, 2009
Study Start
February 1, 2008
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
April 12, 2017
Results First Posted
October 10, 2012
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php