Safety, Tolerability, and Immunogenicity of the Human Cyt... | NCT01986010 | Trialant
NCT01986010
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 1, 2021Actual
Enrollment
190Actual
Phase
Phase 1
Conditions
Cytomegalovirus Infections
Interventions
V160 Low Dose IM
V160 Medium Dose IM
V160 High Dose IM
V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM
V160 High Dose plus MAPA 225 µg /dose IM
V160 Maximum Dose IM
Placebo IM
V160 Medium Dose ID
Placebo ID
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01986010
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V160-001
Secondary IDs
Not provided
Brief Title
Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)
Official Title
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Sep 2021
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
Nov 25, 2013Actual
Primary Completion Date
Apr 19, 2016Actual
Completion Date
Mar 14, 2017Actual
First Submitted Date
Nov 11, 2013
First Submission Date that Met QC Criteria
Nov 11, 2013
First Posted Date
Nov 18, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 30, 2021
Results First Submitted that Met QC Criteria
Sep 30, 2021
Results First Posted Date
Nov 1, 2021Actual
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
Sep 30, 2021
Last Update Posted Date
Nov 1, 2021Actual
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
This study will evaluate the safety, tolerability, and immunogenicity of various doses, formulations, and routes of administration of Human Cytomegalovirus (HCMV) vaccine V160 administered in a 3-dose regimen in healthy adults. The initial treatment arm of HCMV seropositive participants will receive V160 Low Dose without adjuvant by intramuscular injection. Escalation of the V160 dose, inclusion of adjuvant, administration by intradermal injection, and vaccination of HCMV seronegative participants will be performed only after review of safety data of previous treatment arms. The purpose of the study is to identify vaccine formulations associated with optimal safety profile and HCMV-specific immune response for evaluation in subsequent clinical studies of V160.
Percentage of Participants With an Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With an Injection-site AE
Injection-site AEs are defined as redness, swelling, and pain/tenderness.
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With a Systemic AE
A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants With a Serious Adverse Event (SAE)
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
In order to evaluate the cellular immune response to the vaccine(s), the HCMV enzyme-linked immunospot (ELISPOT) assay was used to detect interferon gamma (IFN-γ) secreting HCMV-specific cells from peripheral blood mononuclear cells (PBMCs). Results are expressed as the frequency of spot forming cells (SFCs) per million PBMCs (SFC/10^6 PBMCs). Results are presented for the following HCMV proteins: pp65, Immediate early Protein 1 (IE1), Immediate early Protein 2 (IE2), Glycoprotein B (gB), and also for purified HCMV virion stock.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy based on medical history and physical examination
Serologically confirmed to be HCMV seronegative or HCMV seropositive
Agrees to avoid unusual, unaccustomed strenuous, vigorous physical exercise/activity from 72 hours before through 72 hours after each dose of study vaccine
Body weight ≥110 lbs (50 kg) and body mass index (BMI) of 19 to 32 kg/m^2
If of reproductive potential, agrees to the following during the study and for 4 weeks after the last dose of study vaccine: 1) practice abstinence from heterosexual activity, or 2) use or have their partner use 2 allowable methods of birth control during heterosexual activity
Exclusion Criteria:
Has previously received any cytomegalovirus vaccine
Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention
Has history of any severe allergic reaction that required medical intervention
Is pregnant or breastfeeding or expecting to conceive from 2 weeks before the study through 1 month after the last dose of study vaccine
Plans to donate eggs or sperm from study start through 1 month after the last dose of study drug
Has impairment of immunologic function including, but not limited to autoimmune disease, splenectomy, or human immunodeficiency virus acquired immunodeficiency syndrome (HIV/AIDS)
Received systemic corticosteroids for ≥14 consecutive days and has not completed treatment within 30 days of study start
Received immunosuppressive therapy including, but not limited to rapamycin and equivalents, tacrolimus, FK-506, fujimycin, or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic chemotherapy, or other therapy known to interfere with the immune response within 1 year of study start
Has a condition in which repeated venipuncture or injections pose more than minimal risk, such as hemophilia, thrombocytopenia or other severe coagulation disorders, or significantly impaired venous access
Has a condition that requires active medical intervention or monitoring such as diabetes mellitus, autoimmune disease, or a clinically significant chronic medical condition that is considered progressive
Has history within the past 5 years or current drug or alcohol abuse
Has major psychiatric illness
Is legally or mentally incapacitated
Has participated in another clinical study in the past 4 weeks, or plans during the present study to participate in a treatment-based study or a study in which an invasive procedure is performed
Has received valganciclovir, ganciclovir, valacyclovir, foscarnet, or cidofovir from 4 weeks prior to 1 month following each V160 vaccination
Cox KS, Zhang L, Freed DC, Tang A, Zhang S, Zhou Y, Wang IM, Rupp RE, Adler SP, Musey LK, Wang D, Vora KA, Fu TM. Functional Evaluation and Genetic Evolution of Human T-Cell Responses After Vaccination With a Conditionally Replication-Defective Cytomegalovirus Vaccine. J Infect Dis. 2021 Jun 4;223(11):2001-2012. doi: 10.1093/infdis/jiaa631.
Healthy males and females age 18 years of age and older were enrolled in this trial.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10 units (u) V160 vaccination by IM injection on Day 1, Month 1, and Month 6
FG001
HCMV + V160 30u IM
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Jul 10, 2026
Removed Countries
Germany
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Biological: V160 High Dose IM
HCMV- V160 Medium Dose plus MAPA 225 µg IM
Experimental
Participants seronegative for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM
HCMV- V160 High Dose IM
Experimental
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 High Dose IM
HCMV+ V160 High Dose plus MAPA 225 µg IM
Experimental
Participants seropositive for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
Biological: V160 High Dose plus MAPA 225 µg /dose IM
HCMV+ V160 Maximum Dose IM
Experimental
Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Maximum Dose IM
HCMV- V160 High Dose plus MAPA 225 µg IM
Experimental
Participants seronegative for HCMV at Baseline will receive vaccination with V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
Biological: V160 High Dose plus MAPA 225 µg /dose IM
HCMV- V160 Maximum Dose IM
Experimental
Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Biological: V160 Maximum Dose IM
HCMV+ Placebo IM
Placebo Comparator
Participants seropositive for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6
Other: Placebo IM
HCMV- Placebo IM
Placebo Comparator
Participants seronegative for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6
Other: Placebo IM
HCMV+ V160 Medium Dose Intradermal (ID)
Experimental
Participants seropositive for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6
Biological: V160 Medium Dose ID
HCMV- V160 Medium Dose ID
Experimental
Participants seronegative for HCMV at Baseline will receive V160 vaccination by ID injection on Day 1, Month 1, and Month 6
Biological: V160 Medium Dose ID
HCMV+ Placebo ID
Placebo Comparator
Participants seropositive for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6
Other: Placebo ID
HCMV- Placebo ID
Placebo Comparator
Participants seronegative for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6
Other: Placebo ID
V160 Medium Dose IM
Biological
V160 administered as a 0.75 mL intramuscular injection
HCMV+ V160 Medium Dose IM
HCMV- V160 Medium Dose IM
V160 High Dose IM
Biological
V160 administered as a 0.75 mL intramuscular injection
HCMV+ V160 High Dose IM
HCMV- V160 High Dose IM
V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM
Biological
V160 plus MAPA administered as a 0.75 mL intramuscular injection
HCMV- V160 Medium Dose plus MAPA 225 µg IM
V160 High Dose plus MAPA 225 µg /dose IM
Biological
V160 plus MAPA administered as a 0.75 mL intramuscular injection
HCMV+ V160 High Dose plus MAPA 225 µg IM
HCMV- V160 High Dose plus MAPA 225 µg IM
V160 Maximum Dose IM
Biological
V160 administered as a 0.75 mL intramuscular injection
HCMV+ V160 Maximum Dose IM
HCMV- V160 Maximum Dose IM
Placebo IM
Other
Placebo administered as a 0.75 mL intramuscular injection
HCMV+ Placebo IM
HCMV- Placebo IM
V160 Medium Dose ID
Biological
V160 administered as a 0.1 mL intradermal injection
HCMV+ V160 Medium Dose Intradermal (ID)
HCMV- V160 Medium Dose ID
Placebo ID
Other
Placebo administered as a 0.1 mL intradermal injection
HCMV+ Placebo ID
HCMV- Placebo ID
Percentage of Participants With a Serious Vaccine-Related Adverse Event
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. A serious vaccine-related adverse event was determined by the investigator to be related to the vaccine.
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Up to Month 6
Percentage of Participants With Events of Clinical Interest (ECI)
An event of clinical interest (ECI) is identified as any overdose, elevated liver values meeting threshold criteria (aspartate aminotransferase or alanine aminotransferase ≥3x upper limit of normal (ULN); total bilirubin ≥2x ULN, and, at the same time, alkaline phosphatase <2xULN). Additionally, confirmed, diagnosed autoimmune conditions are considered ECIs.
Up to 18 months
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3
Serum samples for measuring neutralizing antibodies using the Merck Neutralizing Antibody (NAb) assay were collected at month 7. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. The primary hypothesis was that for HCMV-seronegative participants, at least 1 of the vaccination groups receiving V160 formulated with or without adjuvant would exhibit higher HCMV-specific neutralizing antibody titers than the placebo group.
Month 7 (1 month after vaccination 3 at Month 6)
Month 7 (1 month after vaccination 3 at Month 6)
Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
In response to HCMV-specific stimulation of whole blood specimens the whole Blood Cytokine Stimulation (WBStim) assay was used to detect the secretion of interferon gamma (IFN -γ) by an ELISA assay. Results are presented for the following HCMV proteins: pp65, IE1, and gB.
Month 7 (1 month after vaccination 3 at Month 6)
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2
Serum samples for measuring neutralizing antibodies using the Merck NAb assay were collected at months 1 and 2. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. Values below the lower limit of titer are represented by NA.
Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1])
Derived
Adler SP, Lewis N, Conlon A, Christiansen MP, Al-Ibrahim M, Rupp R, Fu TM, Bautista O, Tang H, Wang D, Fisher A, Culp T, Das R, Beck K, Tamms G, Musey L; V160-001 Study Group. Phase 1 Clinical Trial of a Conditionally Replication-Defective Human Cytomegalovirus (CMV) Vaccine in CMV-Seronegative Subjects. J Infect Dis. 2019 Jul 2;220(3):411-419. doi: 10.1093/infdis/jiz141.
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
FG002
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
FG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
FG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
FG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
FG006
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
FG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
FG008
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
FG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
FG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
FG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
FG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
FG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
FG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
FG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
FG016
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
FG00013 subjects
FG00114 subjects
FG00214 subjects
FG00310 subjects
FG00411 subjects
FG00519 subjects
FG00610 subjects
FG0074 subjects
FG00812 subjects
FG00910 subjects
FG01010 subjects
FG01111 subjects
FG01210 subjects
FG01311 subjects
FG01416 subjects
FG01511 subjects
FG0164 subjects
Vaccination 1
FG00013 subjects
FG00114 subjects
FG00214 subjects
FG00310 subjects
FG00411 subjects
FG00519 subjects
FG00610 subjects
FG0074 subjects
FG00812 subjects
FG00910 subjects
FG01010 subjects
FG01111 subjects
FG01210 subjects
FG01311 subjects
FG01416 subjects
FG01511 subjects
FG0164 subjects
Vaccination 2
FG00012 subjects
FG00113 subjects
FG00212 subjects
FG00310 subjects
FG0049 subjects
FG00519 subjects
FG00610 subjects
FG0074 subjects
FG00811 subjects
FG00910 subjects
FG01010 subjects
FG01110 subjects
FG01210 subjects
FG0139 subjects
FG01416 subjects
FG01510 subjects
FG0164 subjects
Vaccination 3
FG00010 subjects
FG00110 subjects
FG0029 subjects
FG00310 subjects
FG0049 subjects
FG00515 subjects
FG00610 subjects
FG0074 subjects
FG00810 subjects
FG00910 subjects
FG01010 subjects
FG0118 subjects
FG01210 subjects
FG0139 subjects
FG01413 subjects
FG01510 subjects
FG0164 subjects
COMPLETED
FG0007 subjects
FG0016 subjects
FG0027 subjects
FG0038 subjects
FG0046 subjects
FG00511 subjects
FG00610 subjects
FG0074 subjects
FG0086 subjects
FG0097 subjects
FG0103 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0146 subjects
FG0150 subjects
FG0160 subjects
NOT COMPLETED
FG0006 subjects
FG0018 subjects
FG0027 subjects
FG0032 subjects
FG0045 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0086 subjects
FG0093 subjects
FG0107 subjects
FG01110 subjects
FG01210 subjects
FG01311 subjects
FG01410 subjects
FG01511 subjects
FG0164 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG004
Status Not Recorded
FG0002 subjects
FG0014 subjects
FG0022 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
BG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
BG002
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
BG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
BG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
BG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
BG006
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
BG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
BG008
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
BG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
BG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
BG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
BG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
BG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
BG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
BG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
BG016
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
BG017
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00013
BG00114
BG00214
BG00310
BG00411
BG00519
BG00610
BG0074
BG00812
BG00910
BG01010
BG01111
BG01210
BG01311
BG01416
BG01511
BG0164
BG017190
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00044.1± 14.8
BG00147.7± 14.5
BG00244.9± 13.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
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
Percentage of Participants With an Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Posted
Number
Percentage of participants
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG006
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
OG008
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG016
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00012
OG00114
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG00075.0
OG00192.9
OG00284.6
OG003
Primary
Percentage of Participants With an Injection-site AE
Injection-site AEs are defined as redness, swelling, and pain/tenderness.
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Posted
Number
Percentage of participants
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
Primary
Percentage of Participants With a Systemic AE
A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Posted
Number
Percentage of participants
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG003
HCMV+ V160 100u MAPA IM
Primary
Percentage of Participants With a Serious Adverse Event (SAE)
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Posted
Number
Percentage of participants
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Primary
Percentage of Participants With a Serious Vaccine-Related Adverse Event
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. A serious vaccine-related adverse event was determined by the investigator to be related to the vaccine.
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Posted
Number
Percentage of participants
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Primary
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Posted
Number
Percentage of participants
Up to Month 6
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
Primary
Percentage of Participants With Events of Clinical Interest (ECI)
An event of clinical interest (ECI) is identified as any overdose, elevated liver values meeting threshold criteria (aspartate aminotransferase or alanine aminotransferase ≥3x upper limit of normal (ULN); total bilirubin ≥2x ULN, and, at the same time, alkaline phosphatase <2xULN). Additionally, confirmed, diagnosed autoimmune conditions are considered ECIs.
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Posted
Number
Percentage of participants
Up to 18 months
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Primary
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3
Serum samples for measuring neutralizing antibodies using the Merck Neutralizing Antibody (NAb) assay were collected at month 7. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. The primary hypothesis was that for HCMV-seronegative participants, at least 1 of the vaccination groups receiving V160 formulated with or without adjuvant would exhibit higher HCMV-specific neutralizing antibody titers than the placebo group.
All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid neutralizing antibody result.
Posted
Geometric Mean
95% Confidence Interval
Geometric Mean Titer
Month 7 (1 month after vaccination 3 at Month 6)
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Secondary
Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
In order to evaluate the cellular immune response to the vaccine(s), the HCMV enzyme-linked immunospot (ELISPOT) assay was used to detect interferon gamma (IFN-γ) secreting HCMV-specific cells from peripheral blood mononuclear cells (PBMCs). Results are expressed as the frequency of spot forming cells (SFCs) per million PBMCs (SFC/10^6 PBMCs). Results are presented for the following HCMV proteins: pp65, Immediate early Protein 1 (IE1), Immediate early Protein 2 (IE2), Glycoprotein B (gB), and also for purified HCMV virion stock.
All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid PBMC interferon-gamma result.
Posted
Geometric Mean
95% Confidence Interval
SFC/10^6 PBMCs
Month 7 (1 month after vaccination 3 at Month 6)
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Secondary
Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
In response to HCMV-specific stimulation of whole blood specimens the whole Blood Cytokine Stimulation (WBStim) assay was used to detect the secretion of interferon gamma (IFN -γ) by an ELISA assay. Results are presented for the following HCMV proteins: pp65, IE1, and gB.
All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid whole blood interferon-gamma result.
Posted
Geometric Mean
95% Confidence Interval
ug/mL
Month 7 (1 month after vaccination 3 at Month 6)
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Secondary
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2
Serum samples for measuring neutralizing antibodies using the Merck NAb assay were collected at months 1 and 2. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. Values below the lower limit of titer are represented by NA.
All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid neutralizing antibody result.
Posted
Geometric Mean
95% Confidence Interval
Geometric Mean Titer
Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1])
ID
Title
Description
OG000
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG002
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
Time Frame
Up to 18 months
Description
All randomized participants who received at least 1 vaccination
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
HCMV + V160 10u IM
Participants seropositive for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
0
13
0
13
9
13
EG001
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
0
14
0
14
13
14
EG002
HCMV + V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
0
14
0
14
12
14
EG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
0
10
0
10
10
10
EG004
HCMV + V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
0
11
0
11
11
11
EG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
0
19
0
19
12
19
EG006
HCMV + V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by ID injection on Day 1, Month 1, and Month 6
0
10
0
10
10
10
EG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received placebo vaccination by ID injection on Day 1, Month 1, and Month 6
0
4
0
4
2
4
EG008
HCMV- V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
0
12
0
12
9
12
EG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
0
10
0
10
9
10
EG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
0
10
0
10
9
10
EG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
0
11
0
11
11
11
EG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
0
10
0
10
9
10
EG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
0
11
0
11
10
11
EG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
0
16
0
16
10
16
EG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 vaccination by ID injection on Day 1, Month 1, and Month 6
0
11
0
11
11
11
EG016
HCMV- V160 Placebo ID
Participants seronegative for HCMV at Baseline received placebo vaccination by ID injection on Day 1, Month 1, and Month 6
0
4
0
4
4
4
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymph node pain
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0151 events1 affected11 at risk
EG0160 events0 affected4 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Bowel movement irregularity
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected14 at risk
EG0022 events1 affected14 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected14 at risk
EG0022 events1 affected14 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Asthenia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Axillary pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Chest pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Chills
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected14 at risk
EG0022 events2 affected14 at risk
EG003
Fatigue
General disorders
MedDRA 19.0
Systematic Assessment
EG0009 events6 affected13 at risk
EG00113 events9 affected14 at risk
EG00219 events7 affected14 at risk
EG003
Influenza like illness
General disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site bruising
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site discolouration
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site discomfort
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site erythema
General disorders
MedDRA 19.0
Systematic Assessment
EG0003 events3 affected13 at risk
EG0012 events1 affected14 at risk
EG0023 events3 affected14 at risk
EG003
Injection site hypoaesthesia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site induration
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site joint pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site mass
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site movement impairment
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0022 events2 affected14 at risk
EG003
Injection site pain
General disorders
MedDRA 19.0
Systematic Assessment
EG00013 events6 affected13 at risk
EG00131 events12 affected14 at risk
EG00218 events10 affected14 at risk
EG003
Injection site pruritus
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site rash
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site reaction
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site scab
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site swelling
General disorders
MedDRA 19.0
Systematic Assessment
EG0002 events2 affected13 at risk
EG0011 events1 affected14 at risk
EG0022 events2 affected14 at risk
EG003
Injection site ulcer
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site vesicles
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site warmth
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Malaise
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Oedema peripheral
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0022 events1 affected14 at risk
EG003
Pain
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Pyrexia
General disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Eye infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Infected bite
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Injection site pustule
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Lip injury
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Bacterial test positive
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Blood glucose increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Blood pressure increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Blood urine present
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Body temperature increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Eosinophil count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Eosinophil count increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Monocyte count decreased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0012 events2 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Monocyte count increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Protein urine present
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
White blood cell count increased
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0004 events3 affected13 at risk
EG0011 events1 affected14 at risk
EG0024 events4 affected14 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0004 events2 affected13 at risk
EG0016 events4 affected14 at risk
EG0028 events6 affected14 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG00011 events6 affected13 at risk
EG0014 events4 affected14 at risk
EG00214 events6 affected14 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Migraine
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Poor quality sleep
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Tremor
Nervous system disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Haemorrhage urinary tract
Renal and urinary disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0021 events1 affected14 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Haematoma
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Hot flush
Vascular disorders
MedDRA 19.0
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected14 at risk
EG0020 events0 affected14 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
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
ID
Term
D003586
Cytomegalovirus Infections
Ancestor Terms
ID
Term
D006566
Herpesviridae Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0092 subjects
FG0100 subjects
FG0111 subjects
FG0121 subjects
FG0131 subjects
FG0142 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
FG0150 subjects
FG0160 subjects
2 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0120 subjects
FG0131 subjects
FG0142 subjects
FG0150 subjects
FG0160 subjects
1 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
FG0107 subjects
FG0117 subjects
FG0129 subjects
FG0139 subjects
FG0145 subjects
FG01510 subjects
FG0164 subjects
48.8
± 10.6
BG00446.4± 13.7
BG00546.5± 15.1
BG00651.7± 18.9
BG00747.5± 16.7
BG00845.0± 11.8
BG00932.5± 10.9
BG01039.0± 16.6
BG01141.1± 14.5
BG01253.1± 10.7
BG01340.0± 14.4
BG01444.9± 15.7
BG01536.1± 12.7
BG01631.5± 13.1
BG01744.1± 14.6
9
BG0036
BG0047
BG00510
BG0066
BG0072
BG0087
BG0096
BG0106
BG0116
BG0126
BG0136
BG0148
BG0156
BG0162
BG017109
Male
BG0006
BG0015
BG0025
BG0034
BG0044
BG0059
BG0064
BG0072
BG0085
BG0094
BG0104
BG0115
BG0124
BG0135
BG0148
BG0155
BG0162
BG01781
2
BG0032
BG0041
BG0050
BG0063
BG0070
BG0082
BG0090
BG0101
BG0110
BG0120
BG0132
BG0141
BG0150
BG0160
BG01719
Not Hispanic or Latino
BG0009
BG00113
BG00212
BG0038
BG00410
BG00519
BG0067
BG0074
BG00810
BG00910
BG0108
BG01111
BG01210
BG0139
BG01415
BG01511
BG0164
BG017170
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0101
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0171
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
BG0150
BG0161
BG0173
Asian
BG0000
BG0010
BG0020
BG0030
BG0041
BG0052
BG0061
BG0070
BG0080
BG0090
BG0101
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0175
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0171
Black or African American
BG0004
BG0013
BG0026
BG0034
BG0045
BG0058
BG0060
BG0071
BG0083
BG0092
BG0102
BG0111
BG0121
BG0132
BG0144
BG0151
BG0160
BG01747
White
BG0007
BG00110
BG0027
BG0036
BG0045
BG0058
BG0069
BG0073
BG0088
BG0097
BG0107
BG01110
BG0128
BG0139
BG01410
BG01510
BG0163
BG017127
More than one race
BG0001
BG0011
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0081
BG0091
BG0100
BG0110
BG0121
BG0130
BG0141
BG0150
BG0160
BG0177
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
10
OG00411
OG00519
OG00610
OG0074
OG00812
OG00910
OG01010
OG01111
OG01210
OG01311
OG01416
OG01511
OG0164
100.0
OG004100.0
OG00557.9
OG006100.0
OG00750.0
OG00875.0
OG00990.0
OG01090.0
OG011100.0
OG01290.0
OG01390.9
OG01456.3
OG015100.0
OG016100.0
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG006
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
OG008
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG016
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00012
OG00114
OG00213
OG00310
OG00411
OG00519
OG00610
OG0074
OG00812
OG00910
OG01010
OG01111
OG01210
OG01311
OG01416
OG01511
OG0164
Title
Denominators
Categories
Title
Measurements
OG00058.3
OG00185.7
OG00269.2
OG00380.0
OG004100.0
OG00526.3
OG00690.0
OG0070.0
OG00866.7
OG00980.0
OG01080.0
OG01190.9
OG01290.0
OG01381.8
OG01431.3
OG015100.0
OG01650.0
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG006
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
OG008
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG016
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00012
OG00114
OG00213
OG00310
OG00411
OG00519
OG00610
OG0074
OG00812
OG00910
OG01010
OG01111
OG01210
OG01311
OG01416
OG01511
OG0164
Title
Denominators
Categories
Title
Measurements
OG00066.7
OG00164.3
OG00269.2
OG00390.0
OG00490.9
OG00557.9
OG00680.0
OG00750.0
OG00866.7
OG00990.0
OG01070.0
OG011100.0
OG01270.0
OG01390.9
OG01456.3
OG015100.0
OG016100.0
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG006
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
OG008
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG016
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00012
OG00114
OG00213
OG00310
OG00411
OG00519
OG00610
OG0074
OG00812
OG00910
OG01010
OG01111
OG01210
OG01311
OG01416
OG01511
OG0164
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG006
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
OG008
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG016
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00012
OG00114
OG00213
OG00310
OG00411
OG00519
OG00610
OG0074
OG00812
OG00910
OG01010
OG01111
OG01210
OG01311
OG01416
OG01511
OG0164
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG006
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
OG008
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG016
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00012
OG00114
OG00213
OG00310
OG00411
OG00519
OG00610
OG0074
OG00812
OG00910
OG01010
OG01111
OG01210
OG01311
OG01416
OG01511
OG0164
Title
Denominators
Categories
Title
Measurements
OG0000
OG0017.1
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0119.1
OG0120
OG0139.1
OG0140
OG0159.1
OG0160
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG006
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG007
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
OG008
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG014
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
OG015
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG016
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00012
OG00114
OG00213
OG00310
OG00411
OG00519
OG00610
OG0074
OG00812
OG00910
OG01010
OG01111
OG01210
OG01311
OG01416
OG01511
OG0164
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG006
HCMV+ Placebo IM or ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by IM or ID injection on Day 1, Month 1, and Month 6
OG007
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG008
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG014
HCMV- Placebo IM or ID
Participants seronegative for HCMV at Baseline received placebo by IM or ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00010
OG00111
OG00210
OG00310
OG0049
OG0059
OG00619
OG00710
OG00810
OG00910
OG0109
OG0119
OG01210
OG01311
OG01419
Title
Denominators
Categories
Title
Measurements
OG0003301(2097 to 5197)
OG0014177(2721 to 6412)
OG0027740(4190 to 14297)
OG0035701(3526 to 9218)
OG0043535(2115 to 5907)
OG0058601(5305 to 13944)
OG0062224(1522 to 3249)
OG007328(210 to 511)
OG0081532(1075 to 2182)
OG0091361(886 to 2090)
OG010820(524 to 1285)
OG0112573(1863 to 3553)
OG0121241(699 to 2203)
OG0131261(733 to 2169)
OG01420(20 to 20)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
GMT Ratio: GMT V160/GMT placebo
GMT Ratio
1.5
2-Sided
95
0.8
2.6
Other
OG001
OG006
GMT Ratio: GMT V160/GMT placebo
GMT Ratio
1.9
2-Sided
95
1.1
3.2
Other
OG002
OG006
GMT Ratio: GMT V160/GMT placebo
GMT Ratio
3.5
2-Sided
95
1.6
7.4
Other
OG003
OG006
GMT Ratio: GMT V160/GMT placebo
GMT Ratio
2.6
2-Sided
95
1.4
4.6
Other
OG004
OG006
GMT Ratio: GMT V160/GMT placebo
GMT Ratio
1.6
2-Sided
95
0.9
3.0
Other
OG005
OG006
GMT Ratio: GMT V160/GMT placebo
GMT Ratio
3.9
2-Sided
95
2.2
7.0
Other
OG007
OG014
GMT Ratio: GMT V160/GMT placebo
Two sample t-test
<0.001
Hypothesis is GMT Ratio >1
GMT Ratio
16.4
2-Sided
95
9.5
28.4
Other
OG008
OG014
GMT Ratio: GMT V160/GMT placebo
Two sample t-test
<0.001
Hypothesis is GMT Ratio >1
GMT Ratio
76.6
2-Sided
95
49.5
118.6
Other
OG009
OG014
GMT Ratio: GMT V160/GMT placebo
Two sample t-test
<0.001
Hypothesis is GMT Ratio >1
GMT Ratio
68.1
2-Sided
95
40.1
115.6
Other
OG010
OG014
GMT Ratio: GMT V160/GMT placebo
Two sample t-test
<0.001
Hypothesis is GMT Ratio >1
GMT Ratio
41.0
2-Sided
95
23.8
70.7
Other
OG011
OG014
GMT Ratio: GMT V160/GMT placebo
Two sample t-test
<0.001
Hypothesis is GMT Ratio >1
GMT Ratio
128.6
2-Sided
95
87.0
190.3
Other
OG012
OG014
GMT Ratio: GMT V160/GMT placebo
Two sample t-test
<0.001
Hypothesis is GMT Ratio >1
GMT Ratio
62.0
2-Sided
95
30.5
126.1
Other
OG013
OG014
GMT Ratio: GMT V160/GMT placebo
Two sample t-test
<0.001
Hypothesis is GMT Ratio >1
GMT Ratio
63.0
2-Sided
95
31.9
124.6
Other
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG006
HCMV+ Placebo IM or ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by IM or ID injection on Day 1, Month 1, and Month 6
OG007
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG008
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG014
HCMV- Placebo IM or ID
Participants seronegative for HCMV at Baseline received placebo by IM or ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG0009
OG00110
OG00210
OG0036
OG0048
OG00510
OG00618
OG0078
OG0087
OG00910
OG0106
OG0118
OG01210
OG0137
OG01417
Title
Denominators
Categories
pp65
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0036
ParticipantsOG0048
ParticipantsOG00510
ParticipantsOG00618
ParticipantsOG0078
ParticipantsOG0087
ParticipantsOG00910
ParticipantsOG0106
ParticipantsOG0118
ParticipantsOG01210
ParticipantsOG0137
ParticipantsOG01417
Title
Measurements
OG000819(362 to 1853)
OG001419(174 to 1007)
OG0021384(66 to 2873)
OG003
IE1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0036
IE2
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0028
ParticipantsOG0036
gB
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0028
ParticipantsOG0036
Virus
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0036
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG006
HCMV+ Placebo IM or ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by IM or ID injection on Day 1, Month 1, and Month 6
OG007
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG008
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG014
HCMV- Placebo IM or ID
Participants seronegative for HCMV at Baseline received placebo by IM or ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00010
OG0017
OG0026
OG0037
OG0046
OG0059
OG00615
OG0078
OG0088
OG0099
OG0109
OG0116
OG0127
OG0137
OG01413
Title
Denominators
Categories
pp65
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0037
ParticipantsOG0046
ParticipantsOG0059
ParticipantsOG00614
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0098
ParticipantsOG0109
ParticipantsOG0116
ParticipantsOG0127
ParticipantsOG0137
ParticipantsOG01413
Title
Measurements
OG000168(63 to 445)
OG001193(65 to 571)
OG00279(26 to 242)
OG003
IE1
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0037
gB
ParticipantsOG00010
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0035
OG003
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG004
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG005
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
OG006
HCMV+ Placebo IM or ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by IM or ID injection on Day 1, Month 1, and Month 6
OG007
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG008
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
OG009
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
OG010
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
OG011
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
OG012
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
OG013
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
OG014
HCMV- Placebo IM or ID
Participants seronegative for HCMV at Baseline received placebo by IM or ID injection on Day 1, Month 1, and Month 6
Units
Counts
Participants
OG00012
OG00114
OG00212
OG00310
OG0049
OG00510
OG00623
OG00711
OG00810
OG00910
OG01011
OG01110
OG01210
OG01310
OG01420
Title
Denominators
Categories
Month 1
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00212
ParticipantsOG00310
ParticipantsOG0049
ParticipantsOG00510
ParticipantsOG00623
ParticipantsOG00711
ParticipantsOG00810
ParticipantsOG00910
ParticipantsOG01011
ParticipantsOG01110
ParticipantsOG01210
ParticipantsOG01310
ParticipantsOG01420
Title
Measurements
OG0003124(1887 to 5172)
OG0015186(3252 to 8270)
OG0026232(3764 to 10318)
OG003
Month 2
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG00210
ParticipantsOG00310
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0112 events2 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0101 events1 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0161 events1 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0121 events1 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected19 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0121 events1 affected10 at risk
EG0132 events2 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0161 events1 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected19 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected10 at risk
EG0112 events1 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0161 events1 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0082 events1 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0121 events1 affected10 at risk
EG0131 events1 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0131 events1 affected11 at risk
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10 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0141 events1 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0151 events1 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0131 events1 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
11 events
3 affected
10 at risk
EG0046 events5 affected11 at risk
EG0052 events2 affected19 at risk
EG00610 events3 affected10 at risk
EG0070 events0 affected4 at risk
EG0087 events5 affected12 at risk
EG0093 events2 affected10 at risk
EG0108 events4 affected10 at risk
EG0115 events5 affected11 at risk
EG0127 events3 affected10 at risk
EG0138 events6 affected11 at risk
EG0144 events3 affected16 at risk
EG01514 events5 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0082 events1 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0152 events2 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0041 events1 affected11 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0121 events1 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
2 events
2 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
13 events
5 affected
10 at risk
EG00414 events6 affected11 at risk
EG0056 events5 affected19 at risk
EG00610 events4 affected10 at risk
EG0071 events1 affected4 at risk
EG0089 events5 affected12 at risk
EG00912 events7 affected10 at risk
EG01010 events5 affected10 at risk
EG01118 events9 affected11 at risk
EG01212 events5 affected10 at risk
EG01320 events8 affected11 at risk
EG0145 events4 affected16 at risk
EG01513 events4 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0121 events1 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0161 events1 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0081 events1 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected11 at risk
EG0120 events0 affected10 at risk
EG0131 events1 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
20 events
8 affected
10 at risk
EG0049 events6 affected11 at risk
EG00513 events7 affected19 at risk
EG00621 events6 affected10 at risk
EG0070 events0 affected4 at risk
EG00810 events5 affected12 at risk
EG00918 events7 affected10 at risk
EG01013 events4 affected10 at risk
EG01117 events9 affected11 at risk
EG01215 events4 affected10 at risk
EG01320 events8 affected11 at risk
EG0148 events5 affected16 at risk
EG01527 events9 affected11 at risk
EG0162 events2 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0141 events1 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0131 events1 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0131 events1 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0141 events1 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0092 events2 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0141 events1 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0042 events2 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0101 events1 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0132 events2 affected11 at risk
EG0143 events2 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0101 events1 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0131 events1 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0151 events1 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0053 events1 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected10 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected12 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected10 at risk
EG0111 events1 affected11 at risk
EG0120 events0 affected10 at risk
EG0130 events0 affected11 at risk
EG0140 events0 affected16 at risk
EG0150 events0 affected11 at risk
EG0160 events0 affected4 at risk
1105
(422 to 2892)
OG0041206(565 to 2573)
OG0051080(570 to 2047)
OG006800(457 to 1401)
OG007886(394 to 1993)
OG008468(195 to 1125)
OG009865(429 to 1745)
OG010380(144 to 999)
OG0111325(656 to 2679)
OG012512(174 to 1502)
OG0131145(530 to 2474)
OG01419(11 to 34)
Participants
OG004
8
ParticipantsOG00510
ParticipantsOG00618
ParticipantsOG0078
ParticipantsOG0087
ParticipantsOG00910
ParticipantsOG0106
ParticipantsOG0118
ParticipantsOG01210
ParticipantsOG0137
ParticipantsOG01417
Title
Measurements
OG000855(262 to 2786)
OG001340(85 to 1353)
OG002419(106 to 1660)
OG003370(79 to 1719)
OG004417(116 to 1507)
OG005379(111 to 1299)
OG006200(75 to 533)
OG007776(310 to 1943)
OG008358(123 to 1043)
OG009913(416 to 2003)
OG010577(158 to 2099)
OG011933(384 to 2264)
OG012742(326 to 1688)
OG0131796(702 to 4590)
OG01412(6 to 24)
Participants
OG004
8
ParticipantsOG00510
ParticipantsOG00618
ParticipantsOG0078
ParticipantsOG0087
ParticipantsOG00910
ParticipantsOG0105
ParticipantsOG0118
ParticipantsOG0129
ParticipantsOG0137
ParticipantsOG01417
Title
Measurements
OG000122(48 to 312)
OG001101(47 to 216)
OG002309(151 to 631)
OG00372(34 to 156)
OG00493(32 to 271)
OG00532(18 to 55)
OG00649(32 to 74)
OG007119(45 to 313)
OG00822(8 to 62)
OG00934(15 to 80)
OG010146(35 to 609)
OG01186(32 to 228)
OG012131(52 to 330)
OG013194(66 to 576)
OG01410(4 to 22)
Participants
OG004
8
ParticipantsOG00510
ParticipantsOG00618
ParticipantsOG0078
ParticipantsOG0087
ParticipantsOG00910
ParticipantsOG0106
ParticipantsOG0118
ParticipantsOG0129
ParticipantsOG0137
ParticipantsOG01417
Title
Measurements
OG000195(69 to 555)
OG001287(74 to 1117)
OG0021137(422 to 3063)
OG003217(58 to 806)
OG004253(84 to 761)
OG005294(101 to 852)
OG006140(64 to 306)
OG007105(58 to 190)
OG00814(6 to 32)
OG00938(22 to 66)
OG010185(73 to 469)
OG01186(45 to 165)
OG012135(73 to 249)
OG013174(89 to 339)
OG01418(11 to 29)
Participants
OG004
8
ParticipantsOG00510
ParticipantsOG00618
ParticipantsOG0078
ParticipantsOG0087
ParticipantsOG00910
ParticipantsOG0106
ParticipantsOG0118
ParticipantsOG01210
ParticipantsOG0137
ParticipantsOG01417
Title
Measurements
OG0001190(544 to 2605)
OG001384(114 to 1294)
OG0022134(995 to 4578)
OG0031348(481 to 3772)
OG0041708(732 to 3988)
OG005937(430 to 2044)
OG0061357(714 to 2579)
OG007668(334 to 1334)
OG00879(28 to 224)
OG009268(135 to 534)
OG010621(276 to 1400)
OG011777(420 to 1439)
OG012413(150 to 1139)
OG0131160(597 to 2253)
OG01417(10 to 27)
86
(35 to 209)
OG004211(90 to 492)
OG00564(30 to 136)
OG006112(60 to 210)
OG00764(33 to 122)
OG00897(53 to 176)
OG00924(11 to 56)
OG01089(51 to 156)
OG0118(5 to 14)
OG01228(14 to 56)
OG01324(14 to 39)
OG0145(3 to 7)
Participants
OG004
6
ParticipantsOG0059
ParticipantsOG00615
ParticipantsOG0078
ParticipantsOG0088
ParticipantsOG0099
ParticipantsOG0109
ParticipantsOG0116
ParticipantsOG0127
ParticipantsOG0137
ParticipantsOG01413
Title
Measurements
OG00090(21 to 389)
OG00170(14 to 364)
OG00213(2 to 74)
OG00335(6 to 217)
OG00420(4 to 109)
OG00527(7 to 104)
OG00624(7 to 82)
OG00762(26 to 148)
OG00835(20 to 62)
OG00928(14 to 55)
OG01040(17 to 96)
OG01111(5 to 23)
OG01245(20 to 101)
OG01340(22 to 72)
OG0145(3 to 8)
Participants
OG004
6
ParticipantsOG0059
ParticipantsOG00615
ParticipantsOG0077
ParticipantsOG0087
ParticipantsOG0099
ParticipantsOG0109
ParticipantsOG0115
ParticipantsOG0127
ParticipantsOG0135
ParticipantsOG01412
Title
Measurements
OG00053(16 to 175)
OG00140(8 to 202)
OG00264(11 to 375)
OG00327(3 to 213)
OG00427(6 to 115)
OG00562(18 to 214)
OG00616(6 to 48)
OG0077(4 to 11)
OG00810(6 to 19)
OG0095(3 to 9)
OG0107(4 to 12)
OG01110(6 to 16)
OG0129(6 to 16)
OG0135(3 to 9)
OG0146(4 to 8)
6695
(3854 to 11631)
OG0043831(2140 to 6858)
OG0059127(5253 to 15855)
OG0062335(1485 to 3671)
OG00773(NA to 137)Values below the lower limit of titer are represented by NA.
OG00895(50 to 184)
OG00965(NA to 125)Values below the lower limit of titer are represented by NA.
OG01091(49 to 170)
OG011134(70 to 258)
OG012281(146 to 542)
OG013183(95 to 351)
OG014NA(NA to NA)Values below the lower limit of titer are represented by NA.
Participants
OG004
9
ParticipantsOG00510
ParticipantsOG00622
ParticipantsOG00711
ParticipantsOG00810
ParticipantsOG00910
ParticipantsOG01011
ParticipantsOG01110
ParticipantsOG01210
ParticipantsOG01310
ParticipantsOG01420
Title
Measurements
OG0003144(1893 to 5221)
OG0015443(3472 to 8533)
OG0026959(4088 to 11845)
OG0037022(4126 to 11953)
OG0044261(2432 to 7464)
OG0059412(5529 to 16021)
OG0062313(1468 to 3644)
OG007143(89 to 230)
OG008264(160 to 433)
OG009264(161 to 433)
OG010288(180 to 463)
OG011590(359 to 968)
OG012589(359 to 968)
OG013451(275 to 741)
OG014NA(NA to NA)Values below the lower limit of titer are represented by NA.