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CompletedNCT03486834Updated Jan 23, 2024Results posted

V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)

A Phase 2 interventional study of V160 and Placebo in Cytomegalovirus (CMV) Infections, sponsored by Merck Sharp & Dohme LLC. Completed at 95 sites in 7 countries. Open to female participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
2,200
Allocation
Randomized
Ages
16 Years to 35 Years
Sex
Female
01

Study summary

This study evaluated the safety, tolerability, and efficacy of the cytomegalovirus (CMV) vaccine (V160) administered in a 2-dose or 3-dose regimen to healthy seronegative women 16 to 35 years of age. Participants received blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and were followed to approximately Month 24. The primary hypothesis of the study was that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo.

02

Conditions studied

  • Cytomegalovirus (CMV) Infections

Keywords

  • Prevention of cytomegalovirus infection (CMVi)
03

Who can participate

Ages eligible
16 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy based on medical history and physical examination.
  • Serologically confirmed to be CMV seronegative prior to receiving the first dose of V160/placebo
  • Have direct exposure to young children (≤5 years of age) at home or occupationally
  • Of childbearing potential
  • Agrees to avoid becoming pregnant during the 6-month treatment period and for at least 4 weeks after the last dose of study drug by either 1) practicing abstinence from heterosexual activity, or 2) use a highly-effective method of birth control (as specified in the protocol) during heterosexual activity.

Exclusion criteria

Exclusion Criteria:

  • Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might expose the participant to risk by participating in the trial, confound the results of the trial, or interfere with participation for the full duration of the trial, as assessed by the investigator
  • Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention or of any severe allergic reaction to any vaccine component that required medical intervention.
  • Has a recent (\<72 hours) history of febrile illness (temperature ≥100.4°F/38.0°C, oral equivalent)
  • Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition that requires immunosuppressive medication.
  • Has a condition in which repeated venipuncture or injections pose more than minimal risk for the participant.
  • A woman of childbearing potential (WOCBP) who has a positive pregnancy test at screening or within 24 hours before the first dose of study treatment.
  • Has previously received a CMV vaccine.
  • Had any live virus vaccine administered or scheduled to be administered in the period from 4 weeks prior to, and 4 weeks following receipt of any dose of trial vaccine.
  • Had any inactivated vaccine administered or scheduled within the period from 14 days prior to, through 14 days following, any dose of trial vaccine.
  • Had administration of any immune globulin or blood product within 90 days prior to injection with V160/placebo or scheduled within 30 days thereafter.
  • Received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to trial entry.
  • Received systemic corticosteroids exceeding physiologic replacement doses (≈5 mg/d prednisone equivalent) within 14 days prior to the first vaccination (participants using inhaled, nasal, or topical steroids are considered eligible for the trial).
  • Received any anti-viral agent with proven or potential activity against CMV two weeks prior to vaccination or is likely to receive such an agent within 2 weeks after vaccination.
  • Receiving or has received in the year prior to enrollment immunosuppressive therapies or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic immunotherapy, chemotherapy and other immunosuppressive therapies known to interfere with the immune response. Topical tacrolimus is allowed provided that it is not used within 2 weeks prior to, or 2 weeks following a V160 dose.
  • Participated in another clinical trial in the past 4 weeks, or plans to participate in a treatment-based trial or a trial in which an invasive procedure is to be performed while enrolled in this trial.
  • Plans donation of eggs at any time from signing the informed consent through 1 month after receiving the last dose of the trial V160/placebo.
04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
2,200 participants (actual)

Study arms

  • Experimental
    V160 3-Dose Regimen

    Participants received 3 doses of vaccine V160 (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant \[MAPA\], 4°C stable formulation) administered by intramuscular (IM) injection on Day 1, Month 2, and Month 6.

    Biological: V160

  • Experimental
    V160 2-Dose Regimen

    Participants received 2 doses of vaccine V160 (100 Units/0.5 mL dose with MAPA, 4°C stable formulation) administered IM on Day 1 and Month 6 and a placebo-saline solution at Month 2.

    Biological: V160 · Drug: Placebo

  • Placebo comparator
    Placebo

    Participants received placebo (saline solution) by IM injection on Day 1, Month 2, and Month 6.

    Drug: Placebo

Interventions

  • BiologicalV160

    V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant \[MAPA\], 4°C stable formulation) IM injection.

    Also known as: Human cytomegalovirus vaccine

  • DrugPlacebo

    Saline solution administered as a 0.5 mL IM injection

05

What researchers measure

Primary outcomes

  1. Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)

    Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.

    Time frame: 4 weeks post last vaccination (Month 7) up to ~Month 24

  2. Number of Participants With Solicited Injection-site Adverse Events

    An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.

    Time frame: Up to 5 days after each vaccination

  3. Number of Participants With Solicited Systemic AEs

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.

    Time frame: Up to 14 days after each vaccination

  4. Number of Participants With Vaccine-related Serious Adverse Events

    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed.

    Time frame: Up to 14 days after each vaccination

Secondary outcomes

  1. Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)

    CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed.

    Time frame: 4 weeks post last vaccination (Month 7) up to ~Month 24

06

Results

Posted Nov 10, 2021

Participant flow

Participant flow — Overall Study
MilestoneV160 3-Dose RegimenV160 2-Dose RegimenPlacebo
Started733733734
Treatment 1729729733
Treatment 2680680679
Treatment 3614631622
Completed614631622
Not completed119102112
Withdrew: Withdrawal by subject464652
Withdrew: Adverse event870
Withdrew: Lost to follow-up412439
Withdrew: Non-compliance with study drug220
Withdrew: Physician decision523
Withdrew: Pregnancy101212
Withdrew: Protocol deviation233
Withdrew: Withdrawal by parent/guardian122
Withdrew: Randomized but not treated441

Outcome measures

PrimaryNumber of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)

Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.

Time frame:
4 weeks post last vaccination (Month 7) up to ~Month 24
Reported as:
Count of participants · Participants
Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)
ParticipantsV160 3-Dose RegimenPlacebo
Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)1424
Statistical analysis
  • V160 3-Dose Regimen vs Placebo · Incidence rate estimate: 2.9 · 95% CI 1.6 to 4.9
  • V160 3-Dose Regimen vs Placebo · Incidence rate estimate: 5.1 · 95% CI 3.3 to 7.6
  • V160 3-Dose Regimen vs Placebo · Vaccine efficacy: 42.4 · 95% CI -13.5 to 71.1
PrimaryNumber of Participants With Solicited Injection-site Adverse Events

An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.

Time frame:
Up to 5 days after each vaccination
Reported as:
Count of participants · Participants
Number of Participants With Solicited Injection-site Adverse Events
ParticipantsV160 3-Dose RegimenV160 2-Dose RegimenPlacebo
Number of Participants With Solicited Injection-site Adverse Events683668249
Statistical analysis
  • V160 3-Dose Regimen vs Placebo · Difference in percent: 59.8 · 95% CI 55.8 to 63.5
  • V160 2-Dose Regimen vs Placebo · Difference in percent: 57.6 · 95% CI 53.5 to 61.5
PrimaryNumber of Participants With Solicited Systemic AEs

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.

Time frame:
Up to 14 days after each vaccination
Reported as:
Count of participants · Participants
Number of Participants With Solicited Systemic AEs
ParticipantsV160 3-Dose RegimenV160 2-Dose RegimenPlacebo
Number of Participants With Solicited Systemic AEs621633508
Statistical analysis
  • V160 3-Dose Regimen vs Placebo · Difference in percent: 15.9 · 95% CI 11.7 to 20.1
  • V160 2-Dose Regimen vs Placebo · Difference in percent: 17.4 · 95% CI 13.3 to 21.6
PrimaryNumber of Participants With Vaccine-related Serious Adverse Events

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed.

Time frame:
Up to 14 days after each vaccination
Reported as:
Count of participants · Participants
Number of Participants With Vaccine-related Serious Adverse Events
ParticipantsV160 3-Dose RegimenV160 2-Dose RegimenPlacebo
Number of Participants With Vaccine-related Serious Adverse Events000
Statistical analysis
  • V160 3-Dose Regimen vs Placebo · Difference in percent: 0.0 · 95% CI -0.5 to 0.5
  • V160 2-Dose Regimen vs Placebo · Difference in percent: 0.0 · 95% CI -0.5 to 0.5
SecondaryNumber of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)

CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed.

Time frame:
4 weeks post last vaccination (Month 7) up to ~Month 24
Reported as:
Count of participants · Participants
Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)
ParticipantsV160 2-Dose RegimenPlacebo
Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)3124
Statistical analysis
  • V160 2-Dose Regimen · Incidence rate estimate: 6.7 · 95% CI 4.6 to 9.5
  • Placebo · Incidence rate estimate: 5.1 · 95% CI 3.3 to 7.6
  • V160 2-Dose Regimen · Vaccine efficacy: -32.0 · 95% CI -135.0 to 25.0

Adverse events

Collected over All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
V160 3-Dose Group0/733 (0%)22/728 (3%)697/728 (95.7%)
V160 2-Dose Group0/733 (0%)29/729 (4%)700/729 (96%)
Placebo Group0/734 (0%)26/732 (3.6%)557/732 (76.1%)
Most frequent serious events
Showing 10 of 65
Most frequent serious events
EventV160 3-Dose GroupV160 2-Dose GroupPlacebo Group
Abortion spontaneousPregnancy, puerperium and perinatal conditions2/7286/7297/732
DepressionPsychiatric disorders2/7280/7291/732
CholelithiasisHepatobiliary disorders0/7282/7290/732
PneumoniaInfections and infestations1/7282/7290/732
Urinary tract infectionInfections and infestations0/7282/7290/732
Ankle fractureInjury, poisoning and procedural complications0/7282/7291/732
Anembryonic gestationPregnancy, puerperium and perinatal conditions0/7280/7292/732
Ectopic pregnancyPregnancy, puerperium and perinatal conditions0/7280/7292/732
Abdominal pain lowerGastrointestinal disorders1/7281/7290/732
Oesophageal ulcerGastrointestinal disorders1/7280/7290/732
Most frequent other events
Showing 10 of 12
Most frequent other events
EventV160 3-Dose GroupV160 2-Dose GroupPlacebo Group
Injection site painGeneral disorders680/728664/729239/732
FatigueGeneral disorders457/728461/729357/732
MyalgiaMusculoskeletal and connective tissue disorders455/728424/729200/732
HeadacheNervous system disorders434/728450/729368/732
Injection site erythemaGeneral disorders254/728208/72930/732
Injection site swellingGeneral disorders248/728233/72921/732
ArthralgiaMusculoskeletal and connective tissue disorders162/728162/72976/732
PyrexiaGeneral disorders75/72890/72927/732
Oropharyngeal painRespiratory, thoracic and mediastinal disorders62/72865/72969/732
NauseaGastrointestinal disorders45/72855/72946/732

Baseline characteristics

Age, Continuous
Age, Continuous(Years)V160 3-Dose RegimenV160 2-Dose RegimenPlaceboTotal
Mean26.0 ± 5.026.1 ± 4.925.9 ± 4.926.0 ± 4.9
Sex: Female, Male
Sex: Female, Male(Participants)V160 3-Dose RegimenV160 2-Dose RegimenPlaceboTotal
Female7337337342200
Male0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)V160 3-Dose RegimenV160 2-Dose RegimenPlaceboTotal
Hispanic or Latino144145143432
Not Hispanic or Latino5885855871760
Unknown or Not Reported1348
Race (NIH/OMB)
Race (NIH/OMB)(Participants)V160 3-Dose RegimenV160 2-Dose RegimenPlaceboTotal
American Indian or Alaska Native0145
Asian67619
Native Hawaiian or Other Pacific Islander0000
Black or African American474943139
White6576526651974
More than one race23231662
Unknown or Not Reported0101
07

Study locations

95 sites
  • Alabama Clinical Therapeutics ( Site 0025)
    Birmingham, Alabama 35205, United States
  • Achieve Clinical Research, LLC ( Site 0055)
    Birmingham, Alabama 35216, United States
  • Synexus US Phoenix Southeast ( Site 0057)
    Chandler, Arizona 85224, United States
  • Inland Empire Liver Foundation ( Site 0026)
    Rialto, California 92377, United States
  • Integrated Research of Inland, Inc. ( Site 0042)
    Riverside, California 92506, United States
  • California Research Foundation ( Site 0286)
    San Diego, California 92123, United States
  • Bayview Research Group, LLC ( Site 0012)
    Valley Village, California 91607, United States
  • Diablo Clinical Research, Inc ( Site 0009)
    Walnut Creek, California 94598, United States
  • Emerson Clinical Research Institute ( Site 0297)
    Washington, District of Columbia 20011, United States
  • Clinical Research of South Florida ( Site 0047)
    Coral Gables, Florida 33134, United States
  • Indago Research & Health Center, Inc ( Site 0007)
    Hialeah, Florida 33012, United States
  • NF Research Center LLC ( Site 0013)
    Hialeah, Florida 33012, United States
  • Best Quality Research Inc. ( Site 0031)
    Hialeah, Florida 33016, United States
  • Care Partners Clinical Research, LLC ( Site 0002)
    Jacksonville, Florida 32277, United States
  • L&C Professional Medical Research Institute ( Site 0021)
    Miami, Florida 33144, United States
  • Advanced Medical Research Institute ( Site 0296)
    Miami, Florida 33174, United States
  • Kendall South Medical Center, Inc ( Site 0008)
    Miami, Florida 33185, United States
  • New Age Medical Research Corporation ( Site 0018)
    Miami, Florida 33186, United States
  • Clinical Associates of Orlando, LLC ( Site 0032)
    Orlando, Florida 32806, United States
  • Columbus Regional Research Institute ( Site 0298)
    Columbus, Georgia 31904, United States
  • Heartland Research Associates, LLC ( Site 0044)
    Augusta, Kansas 67010, United States
  • Heartland Research Associates, LLC ( Site 0023)
    Newton, Kansas 67114, United States
  • Heartland Research Associates, LLC ( Site 0019)
    Wichita, Kansas 67205, United States
  • ACC Pediatric Research ( Site 0022)
    Haughton, Louisiana 71037, United States
  • University of Maryland School of Medicine ( Site 0041)
    Baltimore, Maryland 21201, United States
  • St Michaels Med Center ( Site 0285)
    Newark, New Jersey 07102, United States
  • Albuquerque Clinical Trials ( Site 0052)
    Albuquerque, New Mexico 87102, United States
  • Mid Hudson Medical Research ( Site 0294)
    New Windsor, New York 12553, United States
  • Carolina Women's Research and Wellness Center ( Site 0035)
    Durham, North Carolina 27713, United States
  • PMG Research of Raleigh, LLC ( Site 0048)
    Raleigh, North Carolina 27609, United States
  • PMG Research of Wilmington ( Site 0006)
    Wilmington, North Carolina 28401, United States
  • Cincinnati Children's Hospital Medical Center ( Site 0003)
    Cincinnati, Ohio 45229, United States
  • Senders Pediatrics ( Site 0060)
    Cleveland, Ohio 44121, United States
  • Rapid Medical Research, Inc. ( Site 0038)
    Cleveland, Ohio 44122, United States
  • Lynn Health Science Institute ( Site 0287)
    Oklahoma City, Oklahoma 73112, United States
  • Coastal Pediatric Research ( Site 0010)
    Charleston, South Carolina 29414, United States
  • Parkside Pediatric ( Site 0288)
    Greenville, South Carolina 29607, United States
  • Coastal Carolina Research Center ( Site 0053)
    Mount Pleasant, South Carolina 29464, United States
  • Palmetto Clinical Research ( Site 0289)
    Summerville, South Carolina 29485, United States
  • Tekton Research, Inc. ( Site 0036)
    Austin, Texas 78745, United States
  • Coastal Bend Clinical Research ( Site 0299)
    Corpus Christi, Texas 78413, United States
  • Radiant Research - Dallas ( Site 0045)
    Dallas, Texas 75234, United States
  • University of Texas Medical Branch at Galveston ( Site 0049)
    Galveston, Texas 77555-1115, United States
  • Juno Research, LLC ( Site 0293)
    Houston, Texas 77074, United States
  • Accurate Clinical Management, LLC ( Site 0028)
    Pasadena, Texas 77504, United States
  • Diagnostics Research Group ( Site 0001)
    San Antonio, Texas 78229, United States
  • Synexus Research ( Site 0058)
    San Antonio, Texas 78229, United States
  • Crossroads Clinical Research LLC ( Site 0283)
    Victoria, Texas 77901, United States
  • Health Research of Hampton Roads, Inc. ( Site 0014)
    Newport News, Virginia 23606, United States
  • Clinical Research Associates of Tidewater ( Site 0056)
    Norfolk, Virginia 23507, United States
  • York Clinical Research, LLC ( Site 0033)
    Norfolk, Virginia 23510, United States
  • National Clinical Research-Richmond, Inc. ( Site 0051)
    Richmond, Virginia 23294, United States
  • Multicare / Rockwood Clinic ( Site 0034)
    Spokane, Washington 99202, United States
  • Premier Clinical Research Group ( Site 0050)
    Spokane, Washington 99202, United States
  • Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0247)
    Blacktown, New South Wales 2148, Australia
  • Paratus Clinical Kanwal - Trial Clinic ( Site 0243)
    Kanwal, New South Wales 2259, Australia
  • Holdsworth House Medical Practice ( Site 0241)
    Sydney, New South Wales 2010, Australia
  • University of the Sunshine Coast Clinical Trials Centre ( Site 0244)
    Morayfield, Queensland 4506, Australia
  • University of the Sunshine Coast Clinical Trials Centre ( Site 0245)
    Sippy Downs, Queensland 4556, Australia
  • Vaccine Evaluation Center ( Site 0264)
    Vancouver, British Columbia V5Z 4H4, Canada
  • PrimeHealth Clinical Research ( Site 0070)
    Toronto, Ontario M4S 1Y2, Canada
  • Clinique OVO ( Site 0067)
    Montreal, Quebec H4P 2S4, Canada
  • McGill University Health Centre - Vaccine Study Centre ( Site 0064)
    Pierrefonds, Quebec H9H 4Y6, Canada
  • Diex Recherche Sherbrooke Inc. ( Site 0066)
    Sherbrooke, Quebec J1L 0H8, Canada
  • Diex Recherche Victoriaville Inc. ( Site 0068)
    Victoriaville, Quebec G6P 6P6, Canada
  • CHUQ - Unite de Recherche en Sante Publique ( Site 0065)
    Quebec, G1E 7G9, Canada
  • Diex Recherche Quebec Inc ( Site 0069)
    Quebec, G1N 4V3, Canada
  • Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186)
    Espoo, 02230, Finland
  • Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188)
    Helsinki, 00100, Finland
  • Ita-Helsingin Rokotetutkimuskeskus ( Site 0184)
    Helsinki, 00930, Finland
  • Jarvenpaan rokotetutkimuskeskus ( Site 0185)
    Jarvenpaa, 04400, Finland
  • Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190)
    Kokkola, 67100, Finland
  • Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187)
    Oulu, 90220, Finland
  • Pori Vaccine Research Center ( Site 0182)
    Pori, 28100, Finland
  • Seinajoki Vaccine Research Center ( Site 0189)
    Seinajoki, 60100, Finland
  • Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181)
    Tampere, 33100, Finland
  • Turku Vaccine Research Center ( Site 0183)
    Turku, 20520, Finland
  • Rambam Medical Center - Health Care Campus ( Site 0219)
    Haifa, 3109601, Israel
  • Hadassah Ein Kerem Medical Center ( Site 0216)
    Jerusalem, 9112001, Israel
  • Meir MC ( Site 0213)
    Kfar Saba, 4428164, Israel
  • Western Galilee Hospital ( Site 0212)
    Nahariya, 2222214, Israel
  • Rabin Medical Center ( Site 0218)
    Petah-Tikva, 4941492, Israel
  • Sakhnin west neighbourhood ( Site 0211)
    Sakhnin, 3081000, Israel
  • Sourasky Medical Center ( Site 0217)
    Tel Aviv, 6423906, Israel
  • Maccabi Healthcare Services ( Site 0220)
    Tel Aviv, 6789140, Israel
  • Central City Hospital 7 ( Site 0237)
    Ekaterinburg, 620137, Russian Federation
  • Limited Liability Company Medical Centre Aibolit ( Site 0229)
    Kazan, 420073, Russian Federation
  • LLC Scientific Research Medical Complex Your Health. ( Site 0230)
    Kazan, 420097, Russian Federation
  • City Clinical Hospital 13 of Moscow ( Site 0232)
    Moscow, 115280, Russian Federation
  • Antenatal clinic #22 ( Site 0225)
    Saint Petersburg, 194354, Russian Federation
  • Siberian State Medical University ( Site 0231)
    Tomsk, 634050, Russian Federation
  • Hospital Clinic de Barcelona ( Site 0155)
    Barcelona, 08036, Spain
  • Hospital Universitario 12 de Octubre ( Site 0152)
    Madrid, 28041, Spain
  • Hospital Universitario La Paz ( Site 0157)
    Madrid, 28046, Spain
  • Hospital Clinico Universitario de Santiago ( Site 0151)
    Santiago de Compostela, 15706, Spain
08

References and documents

Publications

  • Das R, Blazquez-Gamero D, Bernstein DI, Gantt S, Bautista O, Beck K, Conlon A, Rosenbloom DIS, Wang D, Ritter M, Arnold B, Annunziato P, Russell KL; V160-002 study group. Safety, efficacy, and immunogenicity of a replication-defective human cytomegalovirus vaccine, V160, in cytomegalovirus-seronegative women: a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Infect Dis. 2023 Dec;23(12):1383-1394. doi: 10.1016/S1473-3099(23)00343-2. Epub 2023 Aug 31. PubMed 37660711 ↗

Study documents

  • Protocol and statistical analysis plan · May 7, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

09

Registry details

Key details

Study ID
NCT03486834
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Apr 3, 2018
Start date
Apr 30, 2018
Primary completion
Oct 30, 2020
Completion
Jun 30, 2021
Results posted
Nov 10, 2021
Last update
Jan 23, 2024

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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