ProQuad Dose Selection Study (V221-011)(COMPLETED) | NCT00986232 | Trialant
NCT00986232
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Apr 10, 2015Estimated
Enrollment
1,551Actual
Phase
Phase 2
Conditions
Measles
Mumps
Rubella
Varicella
Interventions
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Comparator: M-M-R II
Comparator: PUVV
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00986232
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V221-011
Secondary IDs
ID
Type
Description
Link
2009_667
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
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Mar 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 1999
Primary Completion Date
Apr 2000Actual
Completion Date
Sep 2000Actual
First Submitted Date
Sep 25, 2009
First Submission Date that Met QC Criteria
Sep 25, 2009
First Posted Date
Sep 29, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 25, 2010
Results First Submitted that Met QC Criteria
Jan 25, 2010
Results First Posted Date
Feb 15, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 23, 2015
Last Update Posted Date
Apr 10, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Measles
Mumps
Rubella
Varicella
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,551Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
ProQuad (low dose)
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
2
Experimental
ProQuad (middle dose)
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
3
Experimental
ProQuad (high dose)
Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
4
Active Comparator
M-M-R II + PUVV
Biological: Comparator: M-M-R II
Biological: Comparator: PUVV
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Biological
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
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
6 weeks postvaccination
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
Other Outcomes
Not provided
Eligibility Module
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
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
18 clinical sites in the United States
Date first participant visit: 08-Apr-1999
Date last participant visit: 03-Apr-2000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ProQuadâ„¢ (Low Dose)
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
FG001
ProQuadâ„¢ (Middle Dose)
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
FG002
ProQuadâ„¢ (High Dose)
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
FG003
M-M-Râ„¢ II + PUVV (Process Upgrade Varicella Vaccine)
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG000387 subjects
FG001393 subjectsExcludes 1 patient who was randomized to receive ProQuad (Middle Dose), but was not vaccinated.
FG002381 subjects
FG003390 subjectsExcludes 1 patient who was randomized to receive M-M-Râ„¢ II + PUVV, but was not vaccinated.
Vaccination Visit 1
FG000387 subjects
FG001393 subjects
FG002381 subjects
FG003390 subjects
Vaccination Visit 2
FG000360 subjects
FG001365 subjects
FG002360 subjects
FG0030 subjects
COMPLETED
FG000336 subjects
FG001343 subjects
FG002346 subjects
FG003370 subjects
NOT COMPLETED
FG00051 subjects
FG00150 subjects
FG00235 subjects
FG00320 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ProQuadâ„¢ (Low Dose)
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
BG001
ProQuadâ„¢ (Middle Dose)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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
The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.
Posted
Number
Participants
6 weeks postvaccination
ID
Title
Description
OG000
ProQuadâ„¢ (Low Dose) After 1 Injection
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG001
Adverse Events Module
Frequency Threshold
1
Time Frame
Participants were followed for safety for 42 days after each scheduled vaccination.
Description
Number of participants reported as "At Risk" is the number of participants with follow-up.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ProQuad (Low Dose) After Injection 1
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bacteremia
Infections and infestations
Merck CRISP
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Asthenia/Fatigue
General disorders
Merck CRISP
Non-systematic Assessment
More Info Module
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.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D008457
Measles
D009107
Mumps
D012409
Rubella
D002644
Chickenpox
Ancestor Terms
ID
Term
D018185
Morbillivirus Infections
D018184
Paramyxoviridae Infections
D018701
Mononegavirales Infections
D012327
RNA Virus Infections
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C050102
measles, mumps, rubella, varicella vaccine
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
1
2
3
ProQuad
Comparator: M-M-R II
Biological
A single 0.5 mL subcutaneous injection at Day 0
4
Comparator: PUVV
Biological
A single 0.5 mL subcutaneous injection at Day 0
4
Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline
6 weeks Postvaccination
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
6 weeks Postvaccination
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).
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)
Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)
6 weeks Postvaccination
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.)
6 weeks Postvaccination
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.)
6 weeks Postvaccination
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.)
6 weeks postvaccination
0 subjects
Lost to Follow-up
FG00019 subjects
FG00112 subjects
FG00212 subjects
FG0037 subjects
Protocol Violation
FG0002 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
Withdrawal by Subject
FG00013 subjects
FG00116 subjects
FG00212 subjects
FG0033 subjects
Missed one or more bleeds
FG00013 subjects
FG00110 subjects
FG0026 subjects
FG0037 subjects
Incomplete safety follow-up
FG0003 subjects
FG0017 subjects
FG0022 subjects
FG0032 subjects
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
BG002
ProQuadâ„¢ (High Dose)
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
BG003
M-M-Râ„¢ II + PUVV (Process Upgrade Varicella Vaccine)
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
BG004
Total
Total of all reporting groups
387
BG001393
BG002381
BG003390
BG0041551
Standard Deviation
Months
Title
Denominators
Categories
Title
Measurements
BG00012.9± 1.5
BG00112.9± 1.5
BG00212.9± 1.5
BG00313.0± 1.7
BG00412.9± 1.5
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000186
BG001181
BG002192
BG003161
BG004720
Male
BG000201
BG001212
BG002189
BG003229
BG004
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
African American
Title
Measurements
BG00065
BG00155
BG00264
BG00354
BG004238
Asian/Pacific
Title
Measurements
BG00019
BG00111
BG00219
BG003
Caucasian
Title
Measurements
BG000241
BG001267
BG002251
BG003
Hispanic
Title
Measurements
BG00034
BG00144
BG00222
BG003
Native American
Title
Measurements
BG0001
BG0011
BG0021
BG003
Other
Title
Measurements
BG00027
BG00115
BG00224
BG003
ProQuadâ„¢ (Low Dose) After 2 Injections
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG002
ProQuadâ„¢ (Middle Dose) After 1 Injection
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG003
ProQuadâ„¢ (Middle Dose) After 2 Injections
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG004
ProQuadâ„¢ (High Dose) After 1 Injection
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG005
ProQuadâ„¢ (High Dose) After 2 Injections
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG006
M-M-Râ„¢ II + PUVV After 1 Injection
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Units
Counts
Participants
OG000310
OG001300
OG002313
OG003303
OG004307
OG005309
OG006320
Title
Denominators
Categories
Title
Measurements
OG000198
OG001299
OG002253
OG003303
OG004272
OG005306
OG006298
Secondary
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
The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.
Posted
Number
Participants
6 weeks postvaccination
ID
Title
Description
OG000
ProQuadâ„¢ (Low Dose) After 1 Injection
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG001
ProQuadâ„¢ (Low Dose) After 2 Injections
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG002
ProQuadâ„¢ (Middle Dose) After 1 Injection
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG003
ProQuadâ„¢ (Middle Dose) After 2 Injections
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG004
ProQuadâ„¢ (High Dose) After 1 Injection
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG005
ProQuadâ„¢ (High Dose) After 2 Injections
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG006
M-M-Râ„¢ II + PUVV After 1 Injection
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Units
Counts
Participants
OG000324
OG001313
OG002342
OG003
Title
Denominators
Categories
Title
Measurements
OG000321
OG001311
OG002338
OG003
Secondary
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
The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.
Posted
Number
Participants
6 weeks Postvaccination
ID
Title
Description
OG000
ProQuadâ„¢ (Low Dose) After 1 Injection
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG001
ProQuadâ„¢ (Low Dose) After 2 Injections
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG002
ProQuadâ„¢ (Middle Dose) After 1 Injection
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG003
ProQuadâ„¢ (Middle Dose) After 2 Injections
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG004
ProQuadâ„¢ (High Dose) After 1 Injection
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG005
ProQuadâ„¢ (High Dose) After 2 Injections
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG006
M-M-Râ„¢ II + PUVV After 1 Injection
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Units
Counts
Participants
OG000334
OG001322
OG002347
OG003
Title
Denominators
Categories
Title
Measurements
OG000333
OG001322
OG002344
OG003
Secondary
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
The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.
Posted
Number
Participants
6 weeks Postvaccination
ID
Title
Description
OG000
ProQuadâ„¢ (Low Dose) After 1 Injection
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG001
ProQuadâ„¢ (Low Dose) After 2 Injections
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG002
ProQuadâ„¢ (Middle Dose) After 1 Injection
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG003
ProQuadâ„¢ (Middle Dose) After 2 Injections
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG004
ProQuadâ„¢ (High Dose) After 1 Injection
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG005
ProQuadâ„¢ (High Dose) After 2 Injections
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG006
M-M-Râ„¢ II + PUVV After 1 Injection
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Units
Counts
Participants
OG000335
OG001319
OG002347
OG003
Title
Denominators
Categories
Title
Measurements
OG000335
OG001319
OG002343
OG003
Secondary
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).
All participants with follow-up for safety were included in the analysis.
Posted
Number
Participants
6 weeks Postvaccination Visit 1 or Visit 2
ID
Title
Description
OG000
ProQuadâ„¢ (Low Dose) After 1 Injection
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG001
ProQuadâ„¢ (Low Dose) After 2 Injections
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG002
ProQuadâ„¢ (Middle Dose) After 1 Injection
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG003
ProQuadâ„¢ (Middle Dose) After 2 Injections
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG004
ProQuadâ„¢ (High Dose) After 1 Injection
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG005
ProQuadâ„¢ (High Dose) After 2 Injections
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG006
M-M-Râ„¢ II + PUVV After 1 Injection
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Units
Counts
Participants
OG000378
OG001353
OG002387
OG003
Title
Denominators
Categories
With Serious Vaccine-Related CAEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
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.)
The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
6 weeks Postvaccination
ID
Title
Description
OG000
ProQuadâ„¢ (Low Dose) After 1 Injection
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG001
ProQuadâ„¢ (Low Dose) After 2 Injections
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG002
ProQuadâ„¢ (Middle Dose) After 1 Injection
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG003
ProQuadâ„¢ (Middle Dose) After 2 Injections
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG004
ProQuadâ„¢ (High Dose) After 1 Injection
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG005
ProQuadâ„¢ (High Dose) After 2 Injections
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG006
M-M-Râ„¢ II + PUVV After 1 Injection
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Units
Counts
Participants
OG000310
OG001300
OG002313
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.7(5.0 to 6.5)
OG001167.7(145.6 to 193.2)
OG00210.5(9.4 to 11.7)
OG003
Secondary
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.)
The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
6 weeks Postvaccination
ID
Title
Description
OG000
ProQuadâ„¢ (Low Dose) After 1 Injection
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG001
ProQuadâ„¢ (Low Dose) After 2 Injections
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG002
ProQuadâ„¢ (Middle Dose) After 1 Injection
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG003
ProQuadâ„¢ (Middle Dose) After 2 Injections
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG004
ProQuadâ„¢ (High Dose) After 1 Injection
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG005
ProQuadâ„¢ (High Dose) After 2 Injections
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG006
M-M-Râ„¢ II + PUVV After 1 Injection
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Units
Counts
Participants
OG000324
OG001313
OG002342
OG003
Title
Denominators
Categories
Title
Measurements
OG000251.8(229.9 to 275.8)
OG001549.7(484.8 to 623.4)
OG002309.5(280.8 to 341.3)
OG003
Secondary
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.)
The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
6 weeks Postvaccination
ID
Title
Description
OG000
ProQuadâ„¢ (Low Dose) After 1 Injection
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG001
ProQuadâ„¢ (Low Dose) After 2 Injections
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG002
ProQuadâ„¢ (Middle Dose) After 1 Injection
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG003
ProQuadâ„¢ (Middle Dose) After 2 Injections
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG004
ProQuadâ„¢ (High Dose) After 1 Injection
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG005
ProQuadâ„¢ (High Dose) After 2 Injections
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG006
M-M-Râ„¢ II + PUVV After 1 Injection
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Units
Counts
Participants
OG000334
OG001322
OG002347
OG003
Title
Denominators
Categories
Title
Measurements
OG000102.0(90.0 to 115.7)
OG001277.7(252.0 to 305.9)
OG002106.3(94.4 to 119.8)
OG003
Secondary
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.)
The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
Posted
Geometric Mean
95% Confidence Interval
mcg/mL
6 weeks postvaccination
ID
Title
Description
OG000
ProQuadâ„¢ (Low Dose) After 1 Injection
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG001
ProQuadâ„¢ (Low Dose) After 2 Injections
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG002
ProQuadâ„¢ (Middle Dose) After 1 Injection
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG003
ProQuadâ„¢ (Middle Dose) After 2 Injections
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG004
ProQuadâ„¢ (High Dose) After 1 Injection
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG005
ProQuadâ„¢ (High Dose) After 2 Injections
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
OG006
M-M-Râ„¢ II + PUVV After 1 Injection
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
Units
Counts
Participants
OG000335
OG001319
OG002347
OG003
Title
Denominators
Categories
Title
Measurements
OG000131.4(119.6 to 144.5)
OG001263.7(239.0 to 291.0)
OG002122.5(110.7 to 135.5)
OG003
2
378
286
378
EG001
ProQuad (Middle Dose) After Injection 1
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
3
387
286
387
EG002
ProQuad (High Dose) After Injection 1
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
1
377
289
377
EG003
M-M-Râ„¢ II + PUVV (Process Upgrade Varicella Vaccine)
One M-M-Râ„¢ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
1
381
297
381
EG004
ProQuad (Low Dose) After Injection 2
One ProQuadâ„¢ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
1
353
253
353
EG005
ProQuad (Middle Dose) After Injection 2
One ProQuadâ„¢ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
0
361
258
361
EG006
ProQuad (High Dose) After Injection 2
One ProQuadâ„¢ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
2
358
254
358
EG0000 affected378 at risk
EG0011 affected387 at risk
EG0020 affected377 at risk
EG0030 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0060 affected358 at risk
Fever
General disorders
Merck CRISP
Systematic Assessment
EG0000 affected378 at risk
EG0011 affected387 at risk
EG0020 affected377 at risk
EG0030 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0061 affected358 at risk
Diarrhea
Gastrointestinal disorders
Merck CRISP
Non-systematic Assessment
EG0000 affected378 at risk
EG0010 affected387 at risk
EG0020 affected377 at risk
EG0030 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0061 affected358 at risk
Acidosis
Metabolism and nutrition disorders
Merck CRISP
Non-systematic Assessment
EG0000 affected378 at risk
EG0011 affected387 at risk
EG0020 affected377 at risk
EG0030 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0060 affected358 at risk
Dehydration
Metabolism and nutrition disorders
Merck CRISP
Non-systematic Assessment
EG0000 affected378 at risk
EG0010 affected387 at risk
EG0020 affected377 at risk
EG0030 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0062 affected358 at risk
Seizure, febrile
Nervous system disorders
Merck CRISP
Non-systematic Assessment
EG0000 affected378 at risk
EG0011 affected387 at risk
EG0020 affected377 at risk
EG0031 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0060 affected358 at risk
Laryngotracheobronchitis
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0001 affected378 at risk
EG0010 affected387 at risk
EG0020 affected377 at risk
EG0030 affected381 at risk
EG0041 affected353 at risk
EG0050 affected361 at risk
EG0060 affected358 at risk
Respiratory distress, newborn
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0001 affected378 at risk
EG0010 affected387 at risk
EG0020 affected377 at risk
EG0030 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0060 affected358 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0001 affected378 at risk
EG0011 affected387 at risk
EG0021 affected377 at risk
EG0030 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0060 affected358 at risk
Otitis media
Ear and labyrinth disorders
Merck CRISP
Non-systematic Assessment
EG0000 affected378 at risk
EG0010 affected387 at risk
EG0020 affected377 at risk
EG0030 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0061 affected358 at risk
EG0002 affected378 at risk
EG0011 affected387 at risk
EG0024 affected377 at risk
EG0032 affected381 at risk
EG0041 affected353 at risk
EG0051 affected361 at risk
EG0060 affected358 at risk
Candidiasis
General disorders
Merck CRISP
Non-systematic Assessment
EG0001 affected378 at risk
EG0011 affected387 at risk
EG0024 affected377 at risk
EG0032 affected381 at risk
EG0044 affected353 at risk
EG0051 affected361 at risk
EG0062 affected358 at risk
Fever
General disorders
Merck CRISP
Systematic Assessment
EG000116 affected378 at risk
EG001128 affected387 at risk
EG002145 affected377 at risk
EG003136 affected381 at risk
EG00481 affected353 at risk
EG00598 affected361 at risk
EG00699 affected358 at risk
Infection, Viral
Infections and infestations
Merck CRISP
Non-systematic Assessment
EG00012 affected378 at risk
EG00116 affected387 at risk
EG00216 affected377 at risk
EG00314 affected381 at risk
EG00410 affected353 at risk
EG00511 affected361 at risk
EG00614 affected358 at risk
Malaise
General disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0012 affected387 at risk
EG0024 affected377 at risk
EG0031 affected381 at risk
EG0042 affected353 at risk
EG0050 affected361 at risk
EG0062 affected358 at risk
Trauma
Injury, poisoning and procedural complications
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0018 affected387 at risk
EG0021 affected377 at risk
EG0034 affected381 at risk
EG0042 affected353 at risk
EG0053 affected361 at risk
EG0063 affected358 at risk
Anorexia
Metabolism and nutrition disorders
Merck CRISP
Non-systematic Assessment
EG0008 affected378 at risk
EG00110 affected387 at risk
EG0026 affected377 at risk
EG0036 affected381 at risk
EG0043 affected353 at risk
EG0056 affected361 at risk
EG0061 affected358 at risk
Candidiasis, Oral
Gastrointestinal disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0011 affected387 at risk
EG0021 affected377 at risk
EG0031 affected381 at risk
EG0040 affected353 at risk
EG0052 affected361 at risk
EG0060 affected358 at risk
Constipation
Gastrointestinal disorders
Merck CRISP
Non-systematic Assessment
EG0006 affected378 at risk
EG0012 affected387 at risk
EG0022 affected377 at risk
EG0032 affected381 at risk
EG0043 affected353 at risk
EG0051 affected361 at risk
EG0062 affected358 at risk
Diarrhea
Gastrointestinal disorders
Merck CRISP
Non-systematic Assessment
EG00034 affected378 at risk
EG00123 affected387 at risk
EG00231 affected377 at risk
EG00331 affected381 at risk
EG00419 affected353 at risk
EG00526 affected361 at risk
EG00616 affected358 at risk
Flatulence
Gastrointestinal disorders
Merck CRISP
Non-systematic Assessment
EG0001 affected378 at risk
EG0010 affected387 at risk
EG0021 affected377 at risk
EG0035 affected381 at risk
EG0040 affected353 at risk
EG0051 affected361 at risk
EG0060 affected358 at risk
Gastroenteritis
Gastrointestinal disorders
Merck CRISP
Non-systematic Assessment
EG0001 affected378 at risk
EG0013 affected387 at risk
EG0024 affected377 at risk
EG0035 affected381 at risk
EG0045 affected353 at risk
EG0054 affected361 at risk
EG0065 affected358 at risk
Gastroenteritis, Infectious
Gastrointestinal disorders
Merck CRISP
Non-systematic Assessment
EG0008 affected378 at risk
EG0014 affected387 at risk
EG0025 affected377 at risk
EG0032 affected381 at risk
EG0042 affected353 at risk
EG0051 affected361 at risk
EG0063 affected358 at risk
Vomiting
Gastrointestinal disorders
Merck CRISP
Non-systematic Assessment
EG00012 affected378 at risk
EG00116 affected387 at risk
EG00221 affected377 at risk
EG00323 affected381 at risk
EG00419 affected353 at risk
EG00517 affected361 at risk
EG00623 affected358 at risk
Lymphadenopathy
Blood and lymphatic system disorders
Merck CRISP
Non-systematic Assessment
EG0001 affected378 at risk
EG0011 affected387 at risk
EG0024 affected377 at risk
EG0030 affected381 at risk
EG0040 affected353 at risk
EG0050 affected361 at risk
EG0060 affected358 at risk
Allergy
Immune system disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0014 affected387 at risk
EG0023 affected377 at risk
EG0033 affected381 at risk
EG0041 affected353 at risk
EG0054 affected361 at risk
EG0062 affected358 at risk
Crying
Nervous system disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0014 affected387 at risk
EG0021 affected377 at risk
EG0033 affected381 at risk
EG0042 affected353 at risk
EG0050 affected361 at risk
EG0063 affected358 at risk
Irritability
Psychiatric disorders
Merck CRISP
Non-systematic Assessment
EG00052 affected378 at risk
EG00149 affected387 at risk
EG00251 affected377 at risk
EG00342 affected381 at risk
EG00429 affected353 at risk
EG00528 affected361 at risk
EG00629 affected358 at risk
Somnolence
Psychiatric disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0011 affected387 at risk
EG0021 affected377 at risk
EG0031 affected381 at risk
EG0040 affected353 at risk
EG0051 affected361 at risk
EG0062 affected358 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0000 affected378 at risk
EG0016 affected387 at risk
EG0023 affected377 at risk
EG0034 affected381 at risk
EG0046 affected353 at risk
EG0056 affected361 at risk
EG00613 affected358 at risk
Bronchiolitis
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0003 affected378 at risk
EG0014 affected387 at risk
EG0021 affected377 at risk
EG0031 affected381 at risk
EG0041 affected353 at risk
EG0052 affected361 at risk
EG0064 affected358 at risk
Congestion, Nasal
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG00110 affected387 at risk
EG0029 affected377 at risk
EG0035 affected381 at risk
EG0046 affected353 at risk
EG0053 affected361 at risk
EG0066 affected358 at risk
Congestion, Respiratory
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0006 affected378 at risk
EG00114 affected387 at risk
EG0027 affected377 at risk
EG0038 affected381 at risk
EG00413 affected353 at risk
EG00520 affected361 at risk
EG00610 affected358 at risk
Cough
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG00021 affected378 at risk
EG00120 affected387 at risk
EG00220 affected377 at risk
EG00325 affected381 at risk
EG00426 affected353 at risk
EG00533 affected361 at risk
EG00632 affected358 at risk
Infection, Respiratory, Upper
Infections and infestations
Merck CRISP
Non-systematic Assessment
EG00060 affected378 at risk
EG00158 affected387 at risk
EG00267 affected377 at risk
EG00364 affected381 at risk
EG00482 affected353 at risk
EG005110 affected361 at risk
EG00693 affected358 at risk
Influenza
Infections and infestations
Merck CRISP
Non-systematic Assessment
EG0000 affected378 at risk
EG0010 affected387 at risk
EG0023 affected377 at risk
EG0031 affected381 at risk
EG0045 affected353 at risk
EG0052 affected361 at risk
EG0065 affected358 at risk
Laryngotracheobronchitis
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0003 affected378 at risk
EG0013 affected387 at risk
EG0028 affected377 at risk
EG0034 affected381 at risk
EG0048 affected353 at risk
EG0056 affected361 at risk
EG0067 affected358 at risk
Pharyngitis
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0006 affected378 at risk
EG0014 affected387 at risk
EG00210 affected377 at risk
EG00313 affected381 at risk
EG0047 affected353 at risk
EG0056 affected361 at risk
EG00611 affected358 at risk
Pneumonia
Infections and infestations
Merck CRISP
Non-systematic Assessment
EG0000 affected378 at risk
EG0012 affected387 at risk
EG0020 affected377 at risk
EG0033 affected381 at risk
EG0040 affected353 at risk
EG0053 affected361 at risk
EG0064 affected358 at risk
Rhinitis
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0002 affected378 at risk
EG0015 affected387 at risk
EG0022 affected377 at risk
EG0031 affected381 at risk
EG0042 affected353 at risk
EG0053 affected361 at risk
EG0063 affected358 at risk
Rhinorrhea
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG00028 affected378 at risk
EG00134 affected387 at risk
EG00238 affected377 at risk
EG00341 affected381 at risk
EG00428 affected353 at risk
EG00529 affected361 at risk
EG00627 affected358 at risk
Sinusitis
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0005 affected378 at risk
EG0015 affected387 at risk
EG0023 affected377 at risk
EG0035 affected381 at risk
EG0048 affected353 at risk
EG0057 affected361 at risk
EG0066 affected358 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0017 affected387 at risk
EG0020 affected377 at risk
EG0035 affected381 at risk
EG0044 affected353 at risk
EG0054 affected361 at risk
EG0064 affected358 at risk
Bite/Sting, Non-Venomous
Injury, poisoning and procedural complications
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0019 affected387 at risk
EG0024 affected377 at risk
EG0034 affected381 at risk
EG0041 affected353 at risk
EG0051 affected361 at risk
EG0063 affected358 at risk
Burn
Injury, poisoning and procedural complications
Merck CRISP
Non-systematic Assessment
EG0000 affected378 at risk
EG0012 affected387 at risk
EG0024 affected377 at risk
EG0030 affected381 at risk
EG0043 affected353 at risk
EG0050 affected361 at risk
EG0060 affected358 at risk
Dermatitis, Contact
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG0006 affected378 at risk
EG0013 affected387 at risk
EG0027 affected377 at risk
EG0034 affected381 at risk
EG0042 affected353 at risk
EG0054 affected361 at risk
EG0061 affected358 at risk
Eczema
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG0007 affected378 at risk
EG0016 affected387 at risk
EG0024 affected377 at risk
EG0034 affected381 at risk
EG0044 affected353 at risk
EG0054 affected361 at risk
EG0062 affected358 at risk
Miliaria Rubra
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG00010 affected378 at risk
EG0019 affected387 at risk
EG00211 affected377 at risk
EG0037 affected381 at risk
EG0043 affected353 at risk
EG0054 affected361 at risk
EG0060 affected358 at risk
Rash
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG00011 affected378 at risk
EG00115 affected387 at risk
EG00211 affected377 at risk
EG00319 affected381 at risk
EG0047 affected353 at risk
EG00513 affected361 at risk
EG00612 affected358 at risk
Rash, Diaper
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG00016 affected378 at risk
EG0018 affected387 at risk
EG0028 affected377 at risk
EG00314 affected381 at risk
EG0046 affected353 at risk
EG0057 affected361 at risk
EG0067 affected358 at risk
Rash, Measles/Rubella-Like
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG00013 affected378 at risk
EG00118 affected387 at risk
EG00218 affected377 at risk
EG00314 affected381 at risk
EG0041 affected353 at risk
EG0052 affected361 at risk
EG0061 affected358 at risk
Rash, Varicella-Like
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG0008 affected378 at risk
EG00112 affected387 at risk
EG00211 affected377 at risk
EG0038 affected381 at risk
EG0041 affected353 at risk
EG0052 affected361 at risk
EG0062 affected358 at risk
Urticaria
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG0003 affected378 at risk
EG0013 affected387 at risk
EG0021 affected377 at risk
EG0030 affected381 at risk
EG0041 affected353 at risk
EG0050 affected361 at risk
EG0064 affected358 at risk
Viral Exanthema
Infections and infestations
Merck CRISP
Non-systematic Assessment
EG00014 affected378 at risk
EG00116 affected387 at risk
EG00215 affected377 at risk
EG00318 affected381 at risk
EG0046 affected353 at risk
EG0059 affected361 at risk
EG0066 affected358 at risk
Conjunctivitis
Eye disorders
Merck CRISP
Non-systematic Assessment
EG0006 affected378 at risk
EG00110 affected387 at risk
EG00210 affected377 at risk
EG00310 affected381 at risk
EG0045 affected353 at risk
EG0055 affected361 at risk
EG0066 affected358 at risk
Otitis
Ear and labyrinth disorders
Merck CRISP
Non-systematic Assessment
EG00010 affected378 at risk
EG0017 affected387 at risk
EG0026 affected377 at risk
EG0035 affected381 at risk
EG00410 affected353 at risk
EG0053 affected361 at risk
EG0067 affected358 at risk
Otitis Media
Ear and labyrinth disorders
Merck CRISP
Non-systematic Assessment
EG00034 affected378 at risk
EG00137 affected387 at risk
EG00234 affected377 at risk
EG00342 affected381 at risk
EG00453 affected353 at risk
EG00548 affected361 at risk
EG00659 affected358 at risk
Otitis Media, Serous
Ear and labyrinth disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0012 affected387 at risk
EG0021 affected377 at risk
EG0033 affected381 at risk
EG0046 affected353 at risk
EG0050 affected361 at risk
EG0061 affected358 at risk
Pain, Ear
Ear and labyrinth disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0012 affected387 at risk
EG0022 affected377 at risk
EG0033 affected381 at risk
EG0043 affected353 at risk
EG0053 affected361 at risk
EG0064 affected358 at risk
Ecchymosis (ProQuad Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG0004 affected378 at risk
EG0018 affected387 at risk
EG0024 affected377 at risk
EG0030 affected0 at risk
EG0044 affected353 at risk
EG0054 affected361 at risk
EG0062 affected358 at risk
Erythema (ProQuad Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG00048 affected378 at risk
EG00143 affected387 at risk
EG00232 affected377 at risk
EG0030 affected0 at risk
EG00436 affected353 at risk
EG00546 affected361 at risk
EG00638 affected358 at risk
Pain/Tenderness/Soreness (ProQuad Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG00084 affected378 at risk
EG00170 affected387 at risk
EG00278 affected377 at risk
EG0030 affected0 at risk
EG00457 affected353 at risk
EG00552 affected361 at risk
EG00651 affected358 at risk
Rash (ProQuad Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG0007 affected378 at risk
EG0015 affected387 at risk
EG0027 affected377 at risk
EG0030 affected0 at risk
EG0042 affected353 at risk
EG0051 affected361 at risk
EG0062 affected358 at risk
Swelling (ProQuad Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG00029 affected378 at risk
EG00123 affected387 at risk
EG00230 affected377 at risk
EG0030 affected0 at risk
EG00431 affected353 at risk
EG00522 affected361 at risk
EG00621 affected358 at risk
Ecchymosis (M-M-R II Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG0035 affected381 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Erythema (M-M-R II Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG00356 affected381 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Pain/Tenderness/Soreness (M-M-R II Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG00390 affected381 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Swelling (M-M-R II Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG00336 affected381 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Ecchymosis (PUVV Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG0038 affected381 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Erythema (PUVV Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG00348 affected381 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Pain/Tenderness/Soreness (PUVV Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG00385 affected381 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Rash (PUVV Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Non-systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG0037 affected381 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Swelling (PUVV Injection-site)
Skin and subcutaneous tissue disorders
Merck CRISP
Systematic Assessment
EG0000 affected0 at risk
EG0010 affected0 at risk
EG0020 affected0 at risk
EG00332 affected381 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.