ProQuad Dose Selection Study (V221-011)(COMPLETED)
Primary Purpose
Measles, Mumps, Rubella
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Comparator: M-M-R II
Comparator: PUVV
Sponsored by
About this trial
This is an interventional prevention trial for Measles
Eligibility Criteria
Inclusion Criteria:
- In good health
- Negative clinical history of measles, mumps, rubella, varicella, and zoster
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
4
Arm Description
ProQuad (low dose)
ProQuad (middle dose)
ProQuad (high dose)
M-M-R II + PUVV
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline
Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)
Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)
Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)
Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)
Full Information
NCT ID
NCT00986232
First Posted
September 25, 2009
Last Updated
March 23, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00986232
Brief Title
ProQuad Dose Selection Study (V221-011)(COMPLETED)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
April 2000 (Actual)
Study Completion Date
September 2000 (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
A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1551 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ProQuad (low dose)
Arm Title
2
Arm Type
Experimental
Arm Description
ProQuad (middle dose)
Arm Title
3
Arm Type
Experimental
Arm Description
ProQuad (high dose)
Arm Title
4
Arm Type
Active Comparator
Arm Description
M-M-R II + PUVV
Intervention Type
Biological
Intervention Name(s)
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Other Intervention Name(s)
ProQuad
Intervention Description
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
Intervention Type
Biological
Intervention Name(s)
Comparator: M-M-R II
Intervention Description
A single 0.5 mL subcutaneous injection at Day 0
Intervention Type
Biological
Intervention Name(s)
Comparator: PUVV
Intervention Description
A single 0.5 mL subcutaneous injection at Day 0
Primary Outcome Measure Information:
Title
Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
Description
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units
Time Frame
6 weeks postvaccination
Secondary Outcome Measure Information:
Title
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
Description
Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline
Time Frame
6 weeks postvaccination
Title
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
Description
Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline
Time Frame
6 weeks Postvaccination
Title
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
Description
Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline
Time Frame
6 weeks Postvaccination
Title
Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
Description
Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
Time Frame
6 weeks Postvaccination Visit 1 or Visit 2
Title
Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)
Description
Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)
Time Frame
6 weeks Postvaccination
Title
Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
Description
Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)
Time Frame
6 weeks Postvaccination
Title
Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)
Description
Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)
Time Frame
6 weeks Postvaccination
Title
Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)
Description
Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)
Time Frame
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:
In good health
Negative clinical history of measles, mumps, rubella, varicella, and zoster
Exclusion Criteria:
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
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
16094218
Citation
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. Erratum In: Pediatr Infect Dis J. 2005 Nov;24(11):983.
Results Reference
result
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ProQuad Dose Selection Study (V221-011)(COMPLETED)
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