A Study of ProQuad™ in Healthy Children in Korea (V221-023)
Primary Purpose
Measles, Mumps, Rubella
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
M-M-R™ II and Varivax™
Sponsored by
About this trial
This is an interventional prevention trial for Measles focused on measuring Measles, Mumps, Rubella, Varicella
Eligibility Criteria
Inclusion Criteria:
- Subject is in good health
- Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ProQuad™
M-M-R™ II and Varivax™
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Geometric Mean Titer of Measles Antibodies
Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
Geometric Mean Titer of Mumps Antibodies
Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline
Geometric Mean Titer of Rubella Antibodies
Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
Geometric Mean Titer of VZV (gpELISA) Antibodies
Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline
Full Information
NCT ID
NCT00839917
First Posted
February 6, 2009
Last Updated
March 15, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00839917
Brief Title
A Study of ProQuad™ in Healthy Children in Korea (V221-023)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early because of insufficient enrollment before expiration date of the investigational vaccine lot
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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™.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles, Mumps, Rubella, Varicella
Keywords
Measles, Mumps, Rubella, Varicella
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProQuad™
Arm Type
Experimental
Arm Title
M-M-R™ II and Varivax™
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
Other Intervention Name(s)
V221
Intervention Description
Single administration of 0.5 mL subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
M-M-R™ II and Varivax™
Intervention Description
Single administration of 0.5 mL subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
Description
Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
Time Frame
6 weeks postvaccination
Title
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
Description
Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline
Time Frame
6 weeks postvaccination
Title
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
Description
Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
Time Frame
6 weeks postvaccination
Title
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Description
Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline
Time Frame
6 weeks postvaccination
Secondary Outcome Measure Information:
Title
Geometric Mean Titer of Measles Antibodies
Description
Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
Time Frame
6 weeks postvaccination
Title
Geometric Mean Titer of Mumps Antibodies
Description
Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline
Time Frame
6 weeks postvaccination
Title
Geometric Mean Titer of Rubella Antibodies
Description
Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
Time Frame
6 weeks postvaccination
Title
Geometric Mean Titer of VZV (gpELISA) Antibodies
Description
Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline
Time Frame
6 weeks postvaccination
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Measles-like Rash
Time Frame
Through 6 weeks postvaccination
Title
Percentage of Participants With Varicella-like Rash
Time Frame
Through 6 weeks postvaccination
Title
Percentage of Participants With Rubella-like Rash
Time Frame
Through 6 weeks postvaccination
Title
Percentage of Participants With Zoster-like Rash
Time Frame
Through 6 weeks postvaccination
Title
Percentage of Participants With Any Systemic Adverse Experience
Description
An adverse experience is defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences.
Time Frame
Through 6 weeks postvaccination
Title
Percentage of Participants With Injection-site Adverse Experiences
Description
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.
Time Frame
Through 6 weeks postvaccination
Title
Percentage of Participants With Injection-site Adverse Experiences
Description
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.
Time Frame
Through 5 days postvaccination
Title
Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)
Time Frame
Through 6 weeks postvaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is in good health
Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster
Exclusion Criteria:
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)
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
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
A Study of ProQuad™ in Healthy Children in Korea (V221-023)
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