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Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01986010
Collaborator
(none)
190
Enrollment
17
Arms
39.6
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: V160 Low Dose IM
  • Biological: V160 Medium Dose IM
  • Biological: V160 High Dose IM
  • Biological: V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM
  • Biological: V160 High Dose plus MAPA 225 µg /dose IM
  • Biological: V160 Maximum Dose IM
  • Other: Placebo IM
  • Biological: V160 Medium Dose ID
  • Other: Placebo ID
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Nov 25, 2013
Actual Primary Completion Date :
Apr 19, 2016
Actual Study Completion Date :
Mar 14, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: HCMV seropositive (+) V160 Low Dose Intramuscular (IM)

Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Biological: V160 Low Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV seronegative (-) V160 Low Dose IM

Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Biological: V160 Low Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 Medium Dose IM

Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Biological: V160 Medium Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 Medium Dose IM

Participants seronegative for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Biological: V160 Medium Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 High Dose IM

Participants seropositive for HCMV at Baseline will receive V160 vaccination by IM injection on Day 1, Month 1, and Month 6

Biological: V160 High Dose IM
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 Medium Dose plus MAPA 225 µg IM

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
V160 plus MAPA administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 High Dose IM

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
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 High Dose plus MAPA 225 µg IM

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
V160 plus MAPA administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 Maximum Dose IM

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
V160 administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 High Dose plus MAPA 225 µg IM

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
V160 plus MAPA administered as a 0.75 mL intramuscular injection
Experimental: HCMV- V160 Maximum Dose IM

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
V160 administered as a 0.75 mL intramuscular injection
Placebo Comparator: HCMV+ Placebo IM

Participants seropositive for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6

Other: Placebo IM
Placebo administered as a 0.75 mL intramuscular injection
Placebo Comparator: HCMV- Placebo IM

Participants seronegative for HCMV at Baseline will receive placebo by IM injection on Day 1, Month 1, and Month 6

Other: Placebo IM
Placebo administered as a 0.75 mL intramuscular injection
Experimental: HCMV+ V160 Medium Dose Intradermal (ID)

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
V160 administered as a 0.1 mL intradermal injection
Experimental: HCMV- V160 Medium Dose ID

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
V160 administered as a 0.1 mL intradermal injection
Placebo Comparator: HCMV+ Placebo ID

Participants seropositive for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6

Other: Placebo ID
Placebo administered as a 0.1 mL intradermal injection
Placebo Comparator: HCMV- Placebo ID

Participants seronegative for HCMV at Baseline will receive placebo by ID injection on Day 1, Month 1, and Month 6

Other: Placebo ID
Placebo administered as a 0.1 mL intradermal injection

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With an Adverse Event (AE) [Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)]

    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.

  2. Percentage of Participants With an Injection-site AE [Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)]

    Injection-site AEs are defined as redness, swelling, and pain/tenderness.

  3. Percentage of Participants With a Systemic AE [Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)]

    A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain

  4. Percentage of Participants With a Serious Adverse Event (SAE) [Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)]

    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

  5. Percentage of Participants With a Serious Vaccine-Related Adverse Event [Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)]

    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.

  6. Percentage of Participants Who Discontinued Study Treatment Due to an AE [Up to Month 6]

    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.

  7. Percentage of Participants With Events of Clinical Interest (ECI) [Up to 18 months]

    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.

  8. Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3 [Month 7 (1 month after vaccination 3 at Month 6)]

    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.

Secondary Outcome Measures

  1. Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma [Month 7 (1 month after vaccination 3 at Month 6)]

    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.

  2. Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides [Month 7 (1 month after vaccination 3 at Month 6)]

    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.

  3. Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2 [Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1])]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT01986010
Other Study ID Numbers:
  • V160-001
First Posted:
Nov 18, 2013
Last Update Posted:
Nov 1, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Cytomegalovirus Infections
Aluminum phosphate

Study Results

Participant Flow

Recruitment Details Healthy males and females age 18 years of age and older were enrolled in this trial.
Pre-assignment Detail
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ Placebo IM HCMV+ V160 30u ID HCMV+ Placebo ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- Placebo ID
Arm/Group Description 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 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Period Title: Overall Study
STARTED 13 14 14 10 11 19 10 4 12 10 10 11 10 11 16 11 4
Vaccination 1 13 14 14 10 11 19 10 4 12 10 10 11 10 11 16 11 4
Vaccination 2 12 13 12 10 9 19 10 4 11 10 10 10 10 9 16 10 4
Vaccination 3 10 10 9 10 9 15 10 4 10 10 10 8 10 9 13 10 4
COMPLETED 7 6 7 8 6 11 10 4 6 7 3 1 0 0 6 0 0
NOT COMPLETED 6 8 7 2 5 8 0 0 6 3 7 10 10 11 10 11 4

Baseline Characteristics

Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ Placebo IM HCMV+ V160 30u ID HCMV+ Placebo ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- Placebo ID Total
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6 Total of all reporting groups
Overall Participants 13 14 14 10 11 19 10 4 12 10 10 11 10 11 16 11 4 190
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
44.1
(14.8)
47.7
(14.5)
44.9
(13.2)
48.8
(10.6)
46.4
(13.7)
46.5
(15.1)
51.7
(18.9)
47.5
(16.7)
45.0
(11.8)
32.5
(10.9)
39.0
(16.6)
41.1
(14.5)
53.1
(10.7)
40.0
(14.4)
44.9
(15.7)
36.1
(12.7)
31.5
(13.1)
44.1
(14.6)
Sex: Female, Male (Count of Participants)
Female
7
53.8%
9
64.3%
9
64.3%
6
60%
7
63.6%
10
52.6%
6
60%
2
50%
7
58.3%
6
60%
6
60%
6
54.5%
6
60%
6
54.5%
8
50%
6
54.5%
2
50%
109
57.4%
Male
6
46.2%
5
35.7%
5
35.7%
4
40%
4
36.4%
9
47.4%
4
40%
2
50%
5
41.7%
4
40%
4
40%
5
45.5%
4
40%
5
45.5%
8
50%
5
45.5%
2
50%
81
42.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
4
30.8%
1
7.1%
2
14.3%
2
20%
1
9.1%
0
0%
3
30%
0
0%
2
16.7%
0
0%
1
10%
0
0%
0
0%
2
18.2%
1
6.3%
0
0%
0
0%
19
10%
Not Hispanic or Latino
9
69.2%
13
92.9%
12
85.7%
8
80%
10
90.9%
19
100%
7
70%
4
100%
10
83.3%
10
100%
8
80%
11
100%
10
100%
9
81.8%
15
93.8%
11
100%
4
100%
170
89.5%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
10%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
0.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
7.7%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
6.3%
0
0%
1
25%
3
1.6%
Asian
0
0%
0
0%
0
0%
0
0%
1
9.1%
2
10.5%
1
10%
0
0%
0
0%
0
0%
1
10%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
5
2.6%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
0.5%
Black or African American
4
30.8%
3
21.4%
6
42.9%
4
40%
5
45.5%
8
42.1%
0
0%
1
25%
3
25%
2
20%
2
20%
1
9.1%
1
10%
2
18.2%
4
25%
1
9.1%
0
0%
47
24.7%
White
7
53.8%
10
71.4%
7
50%
6
60%
5
45.5%
8
42.1%
9
90%
3
75%
8
66.7%
7
70%
7
70%
10
90.9%
8
80%
9
81.8%
10
62.5%
10
90.9%
3
75%
127
66.8%
More than one race
1
7.7%
1
7.1%
0
0%
0
0%
0
0%
1
5.3%
0
0%
0
0%
1
8.3%
1
10%
0
0%
0
0%
1
10%
0
0%
1
6.3%
0
0%
0
0%
7
3.7%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants With an Adverse Event (AE)
Description 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.
Time Frame Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ Placebo IM HCMV+ V160 30u ID HCMV+ Placebo ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- Placebo ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Measure Participants 12 14 13 10 11 19 10 4 12 10 10 11 10 11 16 11 4
Number [Percentage of participants]
75.0
576.9%
92.9
663.6%
84.6
604.3%
100.0
1000%
100.0
909.1%
57.9
304.7%
100.0
1000%
50.0
1250%
75.0
625%
90.0
900%
90.0
900%
100.0
909.1%
90.0
900%
90.9
826.4%
56.3
351.9%
100.0
909.1%
100.0
2500%
2. Primary Outcome
Title Percentage of Participants With an Injection-site AE
Description Injection-site AEs are defined as redness, swelling, and pain/tenderness.
Time Frame Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ Placebo IM HCMV+ V160 30u ID HCMV+ Placebo ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- Placebo ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Measure Participants 12 14 13 10 11 19 10 4 12 10 10 11 10 11 16 11 4
Number [Percentage of participants]
58.3
448.5%
85.7
612.1%
69.2
494.3%
80.0
800%
100.0
909.1%
26.3
138.4%
90.0
900%
0.0
0%
66.7
555.8%
80.0
800%
80.0
800%
90.9
826.4%
90.0
900%
81.8
743.6%
31.3
195.6%
100.0
909.1%
50.0
1250%
3. Primary Outcome
Title Percentage of Participants With a Systemic AE
Description A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain
Time Frame Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ Placebo IM HCMV+ V160 30u ID HCMV+ Placebo ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- Placebo ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Measure Participants 12 14 13 10 11 19 10 4 12 10 10 11 10 11 16 11 4
Number [Percentage of participants]
66.7
513.1%
64.3
459.3%
69.2
494.3%
90.0
900%
90.9
826.4%
57.9
304.7%
80.0
800%
50.0
1250%
66.7
555.8%
90.0
900%
70.0
700%
100.0
909.1%
70.0
700%
90.9
826.4%
56.3
351.9%
100.0
909.1%
100.0
2500%
4. Primary Outcome
Title Percentage of Participants With a Serious Adverse Event (SAE)
Description 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
Time Frame Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ Placebo IM HCMV+ V160 30u ID HCMV+ Placebo ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- Placebo ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Measure Participants 12 14 13 10 11 19 10 4 12 10 10 11 10 11 16 11 4
Number [Percentage of participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
5. Primary Outcome
Title Percentage of Participants With a Serious Vaccine-Related Adverse Event
Description 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.
Time Frame Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ Placebo IM HCMV+ V160 30u ID HCMV+ Placebo ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- Placebo ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Measure Participants 12 14 13 10 11 19 10 4 12 10 10 11 10 11 16 11 4
Number [Percentage of participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
6. Primary Outcome
Title Percentage of Participants Who Discontinued Study Treatment Due to an AE
Description 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.
Time Frame Up to Month 6

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ Placebo IM HCMV+ V160 30u ID HCMV+ Placebo ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- Placebo ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Measure Participants 12 14 13 10 11 19 10 4 12 10 10 11 10 11 16 11 4
Number [Percentage of participants]
0
0%
7.1
50.7%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
9.1
82.7%
0
0%
9.1
82.7%
0
0%
9.1
82.7%
0
0%
7. Primary Outcome
Title Percentage of Participants With Events of Clinical Interest (ECI)
Description 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.
Time Frame Up to 18 months

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 vaccination and had follow-up safety data available
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ Placebo IM HCMV+ V160 30u ID HCMV+ Placebo ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- Placebo ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
Measure Participants 12 14 13 10 11 19 10 4 12 10 10 11 10 11 16 11 4
Number [Percentage of participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
8. Primary Outcome
Title Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3
Description 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.
Time Frame Month 7 (1 month after vaccination 3 at Month 6)

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid neutralizing antibody result.
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ V160 30u ID HCMV+ Placebo IM or ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 30u ID HCMV- Placebo IM or ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by IM or ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by IM or ID injection on Day 1, Month 1, and Month 6
Measure Participants 10 11 10 10 9 9 19 10 10 10 9 9 10 11 19
Geometric Mean (95% Confidence Interval) [Geometric Mean Titer]
3301
4177
7740
5701
3535
8601
2224
328
1532
1361
820
2573
1241
1261
20
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HCMV Seropositive (+) V160 10u Intramuscular (IM), HCMV+ V160 30u ID
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.8 to 2.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HCMV + V160 30u IM, HCMV+ V160 30u ID
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
1.1 to 3.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HCMV+ V160 100u IM, HCMV+ V160 30u ID
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
1.6 to 7.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection HCMV+ V160 100u MAPA IM, HCMV+ V160 30u ID
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
1.4 to 4.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection HCMV+ V160 250u IM, HCMV+ V160 30u ID
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
0.9 to 3.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection HCMV+ Placebo IM, HCMV+ V160 30u ID
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
2.2 to 7.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection HCMV+ Placebo ID, HCMV- V160 Placebo IM
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments Hypothesis is GMT Ratio >1
Method Two sample t-test
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 16.4
Confidence Interval (2-Sided) 95%
9.5 to 28.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection HCMV Seronegative (-) V160 10u IM, HCMV- V160 Placebo IM
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments Hypothesis is GMT Ratio >1
Method Two sample t-test
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 76.6
Confidence Interval (2-Sided) 95%
49.5 to 118.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection HCMV- V160 30u IM, HCMV- V160 Placebo IM
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments Hypothesis is GMT Ratio >1
Method Two sample t-test
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 68.1
Confidence Interval (2-Sided) 95%
40.1 to 115.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection HCMV- V160 30u MAPA IM, HCMV- V160 Placebo IM
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments Hypothesis is GMT Ratio >1
Method Two sample t-test
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 41.0
Confidence Interval (2-Sided) 95%
23.8 to 70.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection HCMV- V160 100u IM, HCMV- V160 Placebo IM
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments Hypothesis is GMT Ratio >1
Method Two sample t-test
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 128.6
Confidence Interval (2-Sided) 95%
87.0 to 190.3
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection HCMV- V160 100u MAPA IM, HCMV- V160 Placebo IM
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments Hypothesis is GMT Ratio >1
Method Two sample t-test
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 62.0
Confidence Interval (2-Sided) 95%
30.5 to 126.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection HCMV- V160 250u IM, HCMV- V160 Placebo IM
Comments GMT Ratio: GMT V160/GMT placebo
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments Hypothesis is GMT Ratio >1
Method Two sample t-test
Comments
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 63.0
Confidence Interval (2-Sided) 95%
31.9 to 124.6
Parameter Dispersion Type:
Value:
Estimation Comments
9. Secondary Outcome
Title Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
Description 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.
Time Frame Month 7 (1 month after vaccination 3 at Month 6)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ V160 30u ID HCMV+ Placebo IM or ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 30u ID HCMV- Placebo IM or ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by IM or ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by IM or ID injection on Day 1, Month 1, and Month 6
Measure Participants 9 10 10 6 8 10 18 8 7 10 6 8 10 7 17
pp65
819
419
1384
1105
1206
1080
800
886
468
865
380
1325
512
1145
19
IE1
855
340
419
370
417
379
200
776
358
913
577
933
742
1796
12
IE2
122
101
309
72
93
32
49
119
22
34
146
86
131
194
10
gB
195
287
1137
217
253
294
140
105
14
38
185
86
135
174
18
Virus
1190
384
2134
1348
1708
937
1357
668
79
268
621
777
413
1160
17
10. Secondary Outcome
Title Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
Description 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.
Time Frame Month 7 (1 month after vaccination 3 at Month 6)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ V160 30u ID HCMV+ Placebo IM or ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 30u ID HCMV- Placebo IM or ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by IM or ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by IM or ID injection on Day 1, Month 1, and Month 6
Measure Participants 10 7 6 7 6 9 15 8 8 9 9 6 7 7 13
pp65
168
193
79
86
211
64
112
64
97
24
89
8
28
24
5
IE1
90
70
13
35
20
27
24
62
35
28
40
11
45
40
5
gB
53
40
64
27
27
62
16
7
10
5
7
10
9
5
6
11. Secondary Outcome
Title Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2
Description 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.
Time Frame Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1])

Outcome Measure Data

Analysis Population Description
All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid neutralizing antibody result.
Arm/Group Title HCMV Seropositive (+) V160 10u Intramuscular (IM) HCMV + V160 30u IM HCMV+ V160 100u IM HCMV+ V160 100u MAPA IM HCMV+ V160 250u IM HCMV+ V160 30u ID HCMV+ Placebo IM or ID HCMV Seronegative (-) V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 30u ID HCMV- Placebo IM or ID
Arm/Group Description Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 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 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received vaccination with placebo by IM or ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo by IM or ID injection on Day 1, Month 1, and Month 6
Measure Participants 12 14 12 10 9 10 23 11 10 10 11 10 10 10 20
Month 1
3124
5186
6232
6695
3831
9127
2335
73
95
65
91
134
281
183
NA
Month 2
3144
5443
6959
7022
4261
9412
2313
143
264
264
288
590
589
451
NA

Adverse Events

Time Frame Up to 18 months
Adverse Event Reporting Description All randomized participants who received at least 1 vaccination
Arm/Group Title HCMV + V160 10u IM HCMV + V160 30u IM HCMV + V160 100u IM HCMV+ V160 100u MAPA IM HCMV + V160 250u IM HCMV+ Placebo IM HCMV + V160 30u ID HCMV+ Placebo ID HCMV- V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- V160 Placebo ID
Arm/Group Description Participants seropositive for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 100u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received 30u V160 vaccination by ID injection on Day 1, Month 1, and Month 6 Participants seropositive for HCMV at Baseline received placebo vaccination by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received 30u V160 vaccination by ID injection on Day 1, Month 1, and Month 6 Participants seronegative for HCMV at Baseline received placebo vaccination by ID injection on Day 1, Month 1, and Month 6
All Cause Mortality
HCMV + V160 10u IM HCMV + V160 30u IM HCMV + V160 100u IM HCMV+ V160 100u MAPA IM HCMV + V160 250u IM HCMV+ Placebo IM HCMV + V160 30u ID HCMV+ Placebo ID HCMV- V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- V160 Placebo ID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/13 (0%) 0/14 (0%) 0/14 (0%) 0/10 (0%) 0/11 (0%) 0/19 (0%) 0/10 (0%) 0/4 (0%) 0/12 (0%) 0/10 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/11 (0%) 0/16 (0%) 0/11 (0%) 0/4 (0%)
Serious Adverse Events
HCMV + V160 10u IM HCMV + V160 30u IM HCMV + V160 100u IM HCMV+ V160 100u MAPA IM HCMV + V160 250u IM HCMV+ Placebo IM HCMV + V160 30u ID HCMV+ Placebo ID HCMV- V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- V160 Placebo ID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/13 (0%) 0/14 (0%) 0/14 (0%) 0/10 (0%) 0/11 (0%) 0/19 (0%) 0/10 (0%) 0/4 (0%) 0/12 (0%) 0/10 (0%) 0/10 (0%) 0/11 (0%) 0/10 (0%) 0/11 (0%) 0/16 (0%) 0/11 (0%) 0/4 (0%)
Other (Not Including Serious) Adverse Events
HCMV + V160 10u IM HCMV + V160 30u IM HCMV + V160 100u IM HCMV+ V160 100u MAPA IM HCMV + V160 250u IM HCMV+ Placebo IM HCMV + V160 30u ID HCMV+ Placebo ID HCMV- V160 10u IM HCMV- V160 30u IM HCMV- V160 30u MAPA IM HCMV- V160 100u IM HCMV- V160 100u MAPA IM HCMV- V160 250u IM HCMV- V160 Placebo IM HCMV- V160 30u ID HCMV- V160 Placebo ID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 9/13 (69.2%) 13/14 (92.9%) 12/14 (85.7%) 10/10 (100%) 11/11 (100%) 12/19 (63.2%) 10/10 (100%) 2/4 (50%) 9/12 (75%) 9/10 (90%) 9/10 (90%) 11/11 (100%) 9/10 (90%) 10/11 (90.9%) 10/16 (62.5%) 11/11 (100%) 4/4 (100%)
Blood and lymphatic system disorders
Lymph node pain 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Lymphadenopathy 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 2/11 (18.2%) 2 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Ear and labyrinth disorders
Ear discomfort 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Ear pain 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 1/4 (25%) 1
Eye disorders
Eye pruritus 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Periorbital oedema 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Gastrointestinal disorders
Abdominal discomfort 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/19 (5.3%) 1 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 2/11 (18.2%) 2 0/16 (0%) 0 0/11 (0%) 0 1/4 (25%) 1
Abdominal pain upper 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Bowel movement irregularity 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Diarrhoea 1/13 (7.7%) 1 0/14 (0%) 0 1/14 (7.1%) 2 0/10 (0%) 0 0/11 (0%) 0 1/19 (5.3%) 1 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 1/10 (10%) 1 0/10 (0%) 0 1/11 (9.1%) 2 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 1/4 (25%) 1
Dyspepsia 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 1 0/10 (0%) 0 0/11 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0 0/4 (0%) 0 1/12 (8.3%) 2 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Flatulence 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Gastrooesophageal reflux disease 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Nausea 1/13 (7.7%) 1 0/14 (0%) 0 1/14 (7.1%) 2 0/10 (0%) 0 0/11 (0%) 0 1/19 (5.3%) 2 0/10 (0%) 0 0/4 (0%) 0 1/12 (8.3%) 1 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 1/11 (9.1%) 1 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Toothache 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 1/16 (6.3%) 1 0/11 (0%) 0 0/4 (0%) 0
Vomiting 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 2/12 (16.7%) 3 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 1/4 (25%) 1
General disorders
Asthenia 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Axillary pain 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Chest pain 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Chills 0/13 (0%) 0 1/14 (7.1%) 1 2/14 (14.3%) 2 0/10 (0%) 0 2/11 (18.2%) 3 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 1/10 (10%) 1 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 4/11 (36.4%) 6 0/16 (0%) 0 3/11 (27.3%) 3 0/4 (0%) 0
Fatigue 6/13 (46.2%) 9 9/14 (64.3%) 13 7/14 (50%) 19 8/10 (80%) 22 8/11 (72.7%) 19 9/19 (47.4%) 15 6/10 (60%) 22 1/4 (25%) 1 7/12 (58.3%) 15 5/10 (50%) 9 5/10 (50%) 13 6/11 (54.5%) 20 6/10 (60%) 18 10/11 (90.9%) 37 8/16 (50%) 16 8/11 (72.7%) 27 2/4 (50%) 3
Influenza like illness 1/13 (7.7%) 1 0/14 (0%) 0 0/14 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 2/10 (20%) 2 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site bruising 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 1/19 (5.3%) 1 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 2/11 (18.2%) 2 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site discolouration 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site discomfort 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site erythema 3/13 (23.1%) 3 1/14 (7.1%) 2 3/14 (21.4%) 3 2/10 (20%) 2 2/11 (18.2%) 4 3/19 (15.8%) 3 9/10 (90%) 26 0/4 (0%) 0 2/12 (16.7%) 4 1/10 (10%) 3 3/10 (30%) 5 3/11 (27.3%) 4 3/10 (30%) 3 3/11 (27.3%) 6 0/16 (0%) 0 11/11 (100%) 32 2/4 (50%) 2
Injection site hypoaesthesia 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site induration 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site joint pain 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 3 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site mass 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Injection site movement impairment 0/13 (0%) 0 0/14 (0%) 0 2/14 (14.3%) 2 0/10 (0%) 0 1/11 (9.1%) 1 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site pain 6/13 (46.2%) 13 12/14 (85.7%) 31 10/14 (71.4%) 18 7/10 (70%) 21 11/11 (100%) 35 5/19 (26.3%) 10 7/10 (70%) 16 0/4 (0%) 0 8/12 (66.7%) 13 8/10 (80%) 28 8/10 (80%) 19 10/11 (90.9%) 24 8/10 (80%) 28 9/11 (81.8%) 35 5/16 (31.3%) 11 9/11 (81.8%) 23 0/4 (0%) 0
Injection site pruritus 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 7/10 (70%) 14 0/4 (0%) 0 1/12 (8.3%) 1 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 2 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 9/11 (81.8%) 18 0/4 (0%) 0
Injection site rash 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 1/10 (10%) 1 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site reaction 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injection site scab 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Injection site swelling 2/13 (15.4%) 2 1/14 (7.1%) 1 2/14 (14.3%) 2 4/10 (40%) 5 3/11 (27.3%) 5 1/19 (5.3%) 1 9/10 (90%) 27 0/4 (0%) 0 3/12 (25%) 5 1/10 (10%) 3 2/10 (20%) 4 3/11 (27.3%) 5 4/10 (40%) 9 3/11 (27.3%) 4 1/16 (6.3%) 1 11/11 (100%) 34 0/4 (0%) 0
Injection site ulcer 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Injection site vesicles 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Injection site warmth 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 1/10 (10%) 1 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Malaise 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 2/10 (20%) 2 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 2/11 (18.2%) 2 0/4 (0%) 0
Oedema peripheral 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 2 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Pain 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Pyrexia 0/13 (0%) 0 1/14 (7.1%) 1 1/14 (7.1%) 1 0/10 (0%) 0 1/11 (9.1%) 1 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 1/12 (8.3%) 1 1/10 (10%) 1 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 3/11 (27.3%) 3 0/16 (0%) 0 5/11 (45.5%) 5 0/4 (0%) 0
Immune system disorders
Hypersensitivity 0/13 (0%) 0 1/14 (7.1%) 1 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Infections and infestations
Acute sinusitis 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/16 (6.3%) 1 0/11 (0%) 0 0/4 (0%) 0
Conjunctivitis 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Eye infection 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Gingivitis 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Herpes zoster 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Infected bite 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/16 (6.3%) 1 0/11 (0%) 0 0/4 (0%) 0
Injection site pustule 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 2 0/4 (0%) 0
Nasopharyngitis 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 2/10 (20%) 3 3/11 (27.3%) 3 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 1/10 (10%) 1 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Upper respiratory tract infection 1/13 (7.7%) 1 0/14 (0%) 0 0/14 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Viral upper respiratory tract infection 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Injury, poisoning and procedural complications
Arthropod bite 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 1/12 (8.3%) 1 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Laceration 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Ligament sprain 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Lip injury 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Muscle strain 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/16 (6.3%) 1 0/11 (0%) 0 0/4 (0%) 0
Investigations
Alanine aminotransferase increased 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 1/12 (8.3%) 1 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Aspartate aminotransferase increased 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Bacterial test positive 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Blood glucose increased 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Blood phosphorus decreased 0/13 (0%) 0 1/14 (7.1%) 1 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Blood pressure increased 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 1/10 (10%) 1 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Blood urine present 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Body temperature increased 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Eosinophil count decreased 0/13 (0%) 0 1/14 (7.1%) 1 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/16 (6.3%) 1 0/11 (0%) 0 0/4 (0%) 0
Eosinophil count increased 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 1/12 (8.3%) 1 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Haemoglobin decreased 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Monocyte count decreased 0/13 (0%) 0 2/14 (14.3%) 2 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Monocyte count increased 0/13 (0%) 0 1/14 (7.1%) 1 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Protein urine present 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 1/12 (8.3%) 1 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
White blood cell count increased 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
White blood cells urine positive 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Metabolism and nutrition disorders
Decreased appetite 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Dehydration 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Musculoskeletal and connective tissue disorders
Arthralgia 3/13 (23.1%) 4 1/14 (7.1%) 1 4/14 (28.6%) 4 3/10 (30%) 11 5/11 (45.5%) 6 2/19 (10.5%) 2 3/10 (30%) 10 0/4 (0%) 0 5/12 (41.7%) 7 2/10 (20%) 3 4/10 (40%) 8 5/11 (45.5%) 5 3/10 (30%) 7 6/11 (54.5%) 8 3/16 (18.8%) 4 5/11 (45.5%) 14 0/4 (0%) 0
Back pain 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 1/12 (8.3%) 2 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 2/11 (18.2%) 2 0/4 (0%) 0
Muscle spasms 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Muscle tightness 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Muscle twitching 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 1/12 (8.3%) 1 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Musculoskeletal pain 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 2/10 (20%) 2 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 1/10 (10%) 1 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Myalgia 2/13 (15.4%) 4 4/14 (28.6%) 6 6/14 (42.9%) 8 5/10 (50%) 13 6/11 (54.5%) 14 5/19 (26.3%) 6 4/10 (40%) 10 1/4 (25%) 1 5/12 (41.7%) 9 7/10 (70%) 12 5/10 (50%) 10 9/11 (81.8%) 18 5/10 (50%) 12 8/11 (72.7%) 20 4/16 (25%) 5 4/11 (36.4%) 13 0/4 (0%) 0
Pain in extremity 1/13 (7.7%) 1 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 1/4 (25%) 1
Nervous system disorders
Balance disorder 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Dizziness 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 1/12 (8.3%) 1 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Headache 6/13 (46.2%) 11 4/14 (28.6%) 4 6/14 (42.9%) 14 8/10 (80%) 20 6/11 (54.5%) 9 7/19 (36.8%) 13 6/10 (60%) 21 0/4 (0%) 0 5/12 (41.7%) 10 7/10 (70%) 18 4/10 (40%) 13 9/11 (81.8%) 17 4/10 (40%) 15 8/11 (72.7%) 20 5/16 (31.3%) 8 9/11 (81.8%) 27 2/4 (50%) 2
Hypoaesthesia 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/16 (6.3%) 1 0/11 (0%) 0 0/4 (0%) 0
Migraine 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Poor quality sleep 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Tremor 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Psychiatric disorders
Nervousness 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 1/10 (10%) 1 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Renal and urinary disorders
Haemorrhage urinary tract 0/13 (0%) 0 1/14 (7.1%) 1 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Reproductive system and breast disorders
Dysmenorrhoea 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Vaginal discharge 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Respiratory, thoracic and mediastinal disorders
Cough 0/13 (0%) 0 0/14 (0%) 0 1/14 (7.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/16 (6.3%) 1 0/11 (0%) 0 0/4 (0%) 0
Nasal congestion 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 2/10 (20%) 2 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/16 (6.3%) 1 0/11 (0%) 0 0/4 (0%) 0
Oropharyngeal pain 0/13 (0%) 0 1/14 (7.1%) 1 0/14 (0%) 0 0/10 (0%) 0 2/11 (18.2%) 2 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/10 (0%) 0 2/11 (18.2%) 2 2/16 (12.5%) 3 0/11 (0%) 0 0/4 (0%) 0
Skin and subcutaneous tissue disorders
Cold sweat 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 1/10 (10%) 1 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Miliaria 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Night sweats 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0
Pruritus 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 1/19 (5.3%) 3 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Vascular disorders
Haematoma 1/13 (7.7%) 1 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0
Hot flush 0/13 (0%) 0 0/14 (0%) 0 0/14 (0%) 0 0/10 (0%) 0 0/11 (0%) 0 0/19 (0%) 0 0/10 (0%) 0 0/4 (0%) 0 0/12 (0%) 0 0/10 (0%) 0 0/10 (0%) 0 1/11 (9.1%) 1 0/10 (0%) 0 0/11 (0%) 0 0/16 (0%) 0 0/11 (0%) 0 0/4 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title Senior Vice President, Global Clinical Development
Organization Merck Sharp & Dohme Corp.
Phone 1-800-672-6372
Email ClinicalTrialsDisclosure@merck.com
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT01986010
Other Study ID Numbers:
  • V160-001
First Posted:
Nov 18, 2013
Last Update Posted:
Nov 1, 2021
Last Verified:
Sep 1, 2021