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

Primary Purpose

Cytomegalovirus (CMV) Infections

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

V160

Placebo

About this trial

This is an interventional prevention trial for Cytomegalovirus (CMV) Infections focused on measuring Prevention of cytomegalovirus infection (CMVi)

Eligibility Criteria

16 Years - 35 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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:

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.

Sites / Locations

Alabama Clinical Therapeutics ( Site 0025)
Achieve Clinical Research, LLC ( Site 0055)
Synexus US Phoenix Southeast ( Site 0057)
Inland Empire Liver Foundation ( Site 0026)
Integrated Research of Inland, Inc. ( Site 0042)
California Research Foundation ( Site 0286)
Bayview Research Group, LLC ( Site 0012)
Diablo Clinical Research, Inc ( Site 0009)
Emerson Clinical Research Institute ( Site 0297)
Clinical Research of South Florida ( Site 0047)
Indago Research & Health Center, Inc ( Site 0007)
NF Research Center LLC ( Site 0013)
Best Quality Research Inc. ( Site 0031)
Care Partners Clinical Research, LLC ( Site 0002)
L&C Professional Medical Research Institute ( Site 0021)
Advanced Medical Research Institute ( Site 0296)
Kendall South Medical Center, Inc ( Site 0008)
New Age Medical Research Corporation ( Site 0018)
Clinical Associates of Orlando, LLC ( Site 0032)
Columbus Regional Research Institute ( Site 0298)
Heartland Research Associates, LLC ( Site 0044)
Heartland Research Associates, LLC ( Site 0023)
Heartland Research Associates, LLC ( Site 0019)
ACC Pediatric Research ( Site 0022)
University of Maryland School of Medicine ( Site 0041)
St Michaels Med Center ( Site 0285)
Albuquerque Clinical Trials ( Site 0052)
Mid Hudson Medical Research ( Site 0294)
Carolina Women's Research and Wellness Center ( Site 0035)
PMG Research of Raleigh, LLC ( Site 0048)
PMG Research of Wilmington ( Site 0006)
Cincinnati Children's Hospital Medical Center ( Site 0003)
Senders Pediatrics ( Site 0060)
Rapid Medical Research, Inc. ( Site 0038)
Lynn Health Science Institute ( Site 0287)
Coastal Pediatric Research ( Site 0010)
Parkside Pediatric ( Site 0288)
Coastal Carolina Research Center ( Site 0053)
Palmetto Clinical Research ( Site 0289)
Tekton Research, Inc. ( Site 0036)
Coastal Bend Clinical Research ( Site 0299)
Radiant Research - Dallas ( Site 0045)
University of Texas Medical Branch at Galveston ( Site 0049)
Juno Research, LLC ( Site 0293)
Accurate Clinical Management, LLC ( Site 0028)
Diagnostics Research Group ( Site 0001)
Synexus Research ( Site 0058)
Crossroads Clinical Research LLC ( Site 0283)
Health Research of Hampton Roads, Inc. ( Site 0014)
Clinical Research Associates of Tidewater ( Site 0056)
York Clinical Research, LLC ( Site 0033)
National Clinical Research-Richmond, Inc. ( Site 0051)
Multicare / Rockwood Clinic ( Site 0034)
Premier Clinical Research Group ( Site 0050)
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0247)
Paratus Clinical Kanwal - Trial Clinic ( Site 0243)
Holdsworth House Medical Practice ( Site 0241)
University of the Sunshine Coast Clinical Trials Centre ( Site 0244)
University of the Sunshine Coast Clinical Trials Centre ( Site 0245)
Vaccine Evaluation Center ( Site 0264)
PrimeHealth Clinical Research ( Site 0070)
Clinique OVO ( Site 0067)
McGill University Health Centre - Vaccine Study Centre ( Site 0064)
Diex Recherche Sherbrooke Inc. ( Site 0066)
Diex Recherche Victoriaville Inc. ( Site 0068)
CHUQ - Unite de Recherche en Sante Publique ( Site 0065)
Diex Recherche Quebec Inc ( Site 0069)
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186)
Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188)
Ita-Helsingin Rokotetutkimuskeskus ( Site 0184)
Jarvenpaan rokotetutkimuskeskus ( Site 0185)
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190)
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187)
Pori Vaccine Research Center ( Site 0182)
Seinajoki Vaccine Research Center ( Site 0189)
Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181)
Turku Vaccine Research Center ( Site 0183)
Rambam Medical Center - Health Care Campus ( Site 0219)
Hadassah Ein Kerem Medical Center ( Site 0216)
Meir MC ( Site 0213)
Western Galilee Hospital ( Site 0212)
Rabin Medical Center ( Site 0218)
Sakhnin west neighbourhood ( Site 0211)
Sourasky Medical Center ( Site 0217)
Maccabi Healthcare Services ( Site 0220)
Central City Hospital 7 ( Site 0237)
Limited Liability Company Medical Centre Aibolit ( Site 0229)
LLC Scientific Research Medical Complex Your Health. ( Site 0230)
City Clinical Hospital 13 of Moscow ( Site 0232)
Antenatal clinic #22 ( Site 0225)
Siberian State Medical University ( Site 0231)
Hospital Clinic de Barcelona ( Site 0155)
Hospital Universitario 12 de Octubre ( Site 0152)
Hospital Universitario La Paz ( Site 0157)
Hospital Clinico Universitario de Santiago ( Site 0151)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

V160 3-Dose Regimen

V160 2-Dose Regimen

Placebo

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03486834

First Posted

March 28, 2018

Last Updated

October 13, 2021

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03486834

Brief Title

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

Official Title

Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3-Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

April 30, 2018 (Actual)

Primary Completion Date

October 30, 2020 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytomegalovirus (CMV) Infections

Keywords

Prevention of cytomegalovirus infection (CMVi)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V160 3-Dose Regimen

Arm Type

Experimental

Arm Description

Arm Title

V160 2-Dose Regimen

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

V160

Other Intervention Name(s)

Human cytomegalovirus vaccine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Saline solution administered as a 0.5 mL IM injection

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

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

Title

Number of Participants With Solicited Injection-site Adverse Events

Description

Time Frame

Up to 5 days after each vaccination

Title

Number of Participants With Solicited Systemic AEs

Description

Time Frame

Up to 14 days after each vaccination

Title

Number of Participants With Vaccine-related Serious Adverse Events

Description

Time Frame

Up to 14 days after each vaccination

Secondary Outcome Measure Information:

Title

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)

Description

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Alabama Clinical Therapeutics ( Site 0025)

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Achieve Clinical Research, LLC ( Site 0055)

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Synexus US Phoenix Southeast ( Site 0057)

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Inland Empire Liver Foundation ( Site 0026)

City

Rialto

State/Province

California

ZIP/Postal Code

92377

Country

United States

Facility Name

Integrated Research of Inland, Inc. ( Site 0042)

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

California Research Foundation ( Site 0286)

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Bayview Research Group, LLC ( Site 0012)

City

Valley Village

State/Province

California

ZIP/Postal Code

91607

Country

United States

Facility Name

Diablo Clinical Research, Inc ( Site 0009)

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Emerson Clinical Research Institute ( Site 0297)

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20011

Country

United States

Facility Name

Clinical Research of South Florida ( Site 0047)

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Indago Research & Health Center, Inc ( Site 0007)

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

NF Research Center LLC ( Site 0013)

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Best Quality Research Inc. ( Site 0031)

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Care Partners Clinical Research, LLC ( Site 0002)

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32277

Country

United States

Facility Name

L&C Professional Medical Research Institute ( Site 0021)

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Advanced Medical Research Institute ( Site 0296)

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Kendall South Medical Center, Inc ( Site 0008)

City

Miami

State/Province

Florida

ZIP/Postal Code

33185

Country

United States

Facility Name

New Age Medical Research Corporation ( Site 0018)

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Clinical Associates of Orlando, LLC ( Site 0032)

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Columbus Regional Research Institute ( Site 0298)

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Heartland Research Associates, LLC ( Site 0044)

City

Augusta

State/Province

Kansas

ZIP/Postal Code

67010

Country

United States

Facility Name

Heartland Research Associates, LLC ( Site 0023)

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

Heartland Research Associates, LLC ( Site 0019)

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

ACC Pediatric Research ( Site 0022)

City

Haughton

State/Province

Louisiana

ZIP/Postal Code

71037

Country

United States

Facility Name

University of Maryland School of Medicine ( Site 0041)

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

St Michaels Med Center ( Site 0285)

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Facility Name

Albuquerque Clinical Trials ( Site 0052)

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Mid Hudson Medical Research ( Site 0294)

City

New Windsor

State/Province

New York

ZIP/Postal Code

12553

Country

United States

Facility Name

Carolina Women's Research and Wellness Center ( Site 0035)

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27713

Country

United States

Facility Name

PMG Research of Raleigh, LLC ( Site 0048)

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

PMG Research of Wilmington ( Site 0006)

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Cincinnati Children's Hospital Medical Center ( Site 0003)

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Senders Pediatrics ( Site 0060)

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44121

Country

United States

Facility Name

Rapid Medical Research, Inc. ( Site 0038)

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Lynn Health Science Institute ( Site 0287)

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Coastal Pediatric Research ( Site 0010)

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Parkside Pediatric ( Site 0288)

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Coastal Carolina Research Center ( Site 0053)

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Palmetto Clinical Research ( Site 0289)

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29485

Country

United States

Facility Name

Tekton Research, Inc. ( Site 0036)

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Coastal Bend Clinical Research ( Site 0299)

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78413

Country

United States

Facility Name

Radiant Research - Dallas ( Site 0045)

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

University of Texas Medical Branch at Galveston ( Site 0049)

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-1115

Country

United States

Facility Name

Juno Research, LLC ( Site 0293)

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Accurate Clinical Management, LLC ( Site 0028)

City

Pasadena

State/Province

Texas

ZIP/Postal Code

77504

Country

United States

Facility Name

Diagnostics Research Group ( Site 0001)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Synexus Research ( Site 0058)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Crossroads Clinical Research LLC ( Site 0283)

City

Victoria

State/Province

Texas

ZIP/Postal Code

77901

Country

United States

Facility Name

Health Research of Hampton Roads, Inc. ( Site 0014)

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Clinical Research Associates of Tidewater ( Site 0056)

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

York Clinical Research, LLC ( Site 0033)

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

National Clinical Research-Richmond, Inc. ( Site 0051)

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Multicare / Rockwood Clinic ( Site 0034)

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Premier Clinical Research Group ( Site 0050)

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0247)

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Facility Name

Paratus Clinical Kanwal - Trial Clinic ( Site 0243)

City

Kanwal

State/Province

New South Wales

ZIP/Postal Code

2259

Country

Australia

Facility Name

Holdsworth House Medical Practice ( Site 0241)

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

University of the Sunshine Coast Clinical Trials Centre ( Site 0244)

City

Morayfield

State/Province

Queensland

ZIP/Postal Code

4506

Country

Australia

Facility Name

University of the Sunshine Coast Clinical Trials Centre ( Site 0245)

City

Sippy Downs

State/Province

Queensland

ZIP/Postal Code

4556

Country

Australia

Facility Name

Vaccine Evaluation Center ( Site 0264)

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4H4

Country

Canada

Facility Name

PrimeHealth Clinical Research ( Site 0070)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4S 1Y2

Country

Canada

Facility Name

Clinique OVO ( Site 0067)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4P 2S4

Country

Canada

Facility Name

McGill University Health Centre - Vaccine Study Centre ( Site 0064)

City

Pierrefonds

State/Province

Quebec

ZIP/Postal Code

H9H 4Y6

Country

Canada

Facility Name

Diex Recherche Sherbrooke Inc. ( Site 0066)

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1L 0H8

Country

Canada

Facility Name

Diex Recherche Victoriaville Inc. ( Site 0068)

City

Victoriaville

State/Province

Quebec

ZIP/Postal Code

G6P 6P6

Country

Canada

Facility Name

CHUQ - Unite de Recherche en Sante Publique ( Site 0065)

City

Quebec

ZIP/Postal Code

G1E 7G9

Country

Canada

Facility Name

Diex Recherche Quebec Inc ( Site 0069)

City

Quebec

ZIP/Postal Code

G1N 4V3

Country

Canada

Facility Name

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0186)

City

Espoo

ZIP/Postal Code

02230

Country

Finland

Facility Name

Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0188)

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

Ita-Helsingin Rokotetutkimuskeskus ( Site 0184)

City

Helsinki

ZIP/Postal Code

00930

Country

Finland

Facility Name

Jarvenpaan rokotetutkimuskeskus ( Site 0185)

City

Jarvenpaa

ZIP/Postal Code

04400

Country

Finland

Facility Name

Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0190)

City

Kokkola

ZIP/Postal Code

67100

Country

Finland

Facility Name

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0187)

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Pori Vaccine Research Center ( Site 0182)

City

Pori

ZIP/Postal Code

28100

Country

Finland

Facility Name

Seinajoki Vaccine Research Center ( Site 0189)

City

Seinajoki

ZIP/Postal Code

60100

Country

Finland

Facility Name

Tampereen yliopisto Rokotetutkimuskeskus ( Site 0181)

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Turku Vaccine Research Center ( Site 0183)

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Rambam Medical Center - Health Care Campus ( Site 0219)

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Hadassah Ein Kerem Medical Center ( Site 0216)

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Meir MC ( Site 0213)

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Western Galilee Hospital ( Site 0212)

City

Nahariya

ZIP/Postal Code

2222214

Country

Israel

Facility Name

Rabin Medical Center ( Site 0218)

City

Petah-Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Sakhnin west neighbourhood ( Site 0211)

City

Sakhnin

ZIP/Postal Code

3081000

Country

Israel

Facility Name

Sourasky Medical Center ( Site 0217)

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Maccabi Healthcare Services ( Site 0220)

City

Tel Aviv

ZIP/Postal Code

6789140

Country

Israel

Facility Name

Central City Hospital 7 ( Site 0237)

City

Ekaterinburg

ZIP/Postal Code

620137

Country

Russian Federation

Facility Name

Limited Liability Company Medical Centre Aibolit ( Site 0229)

City

Kazan

ZIP/Postal Code

420073

Country

Russian Federation

Facility Name

LLC Scientific Research Medical Complex Your Health. ( Site 0230)

City

Kazan

ZIP/Postal Code

420097

Country

Russian Federation

Facility Name

City Clinical Hospital 13 of Moscow ( Site 0232)

City

Moscow

ZIP/Postal Code

115280

Country

Russian Federation

Facility Name

Antenatal clinic #22 ( Site 0225)

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Siberian State Medical University ( Site 0231)

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Hospital Clinic de Barcelona ( Site 0155)

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre ( Site 0152)

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario La Paz ( Site 0157)

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Clinico Universitario de Santiago ( Site 0151)

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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