search
Back to results

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

Primary Purpose

Pneumococcal Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V116
PCV20
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of an early undetected pregnancy.

Exclusion Criteria:

  • Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
  • Has a known hypersensitivity to any component of V116 or PCV20, including diphtheria toxoid
  • Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
  • Has a coagulation disorder contraindicating IM vaccination
  • Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
  • Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
  • Received prior administration (prior to age of 5 is acceptable) of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
  • Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
  • Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
  • Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
  • Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
  • Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete

Sites / Locations

  • Central Research Associates ( Site 0067)
  • Lenzmeier Family Medicine/CCT Research ( Site 0006)
  • Desert Clinical Research/ CCT Research ( Site 0040)
  • Foothills Research Center/ CCT Research ( Site 0021)
  • Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003)
  • Baptist Health Center For Clinical Research ( Site 0019)
  • Southland Clinical Research Center-Research ( Site 0054)
  • Sunwise Clinical Research ( Site 0024)
  • Chemidox Clinical Trials ( Site 0048)
  • Paradigm Clinical Research Centers, Inc ( Site 0018)
  • Peninsula Research Associates ( Site 0079)
  • Acclaim Clinical Research ( Site 0083)
  • Millennium Clinical Trials ( Site 0013)
  • Lynn Institute of Denver ( Site 0012)
  • Paradigm Clinical Research Centers, Inc ( Site 0027)
  • JEM Research Institute ( Site 0072)
  • Alliance for Multispecialty Research, LLC ( Site 0015)
  • Hillcrest Medical Research ( Site 0049)
  • East Coast Institute for Research, LLC ( Site 0070)
  • East Coast Institute for Research ( Site 0071)
  • L&C Professional Medical Research Institute ( Site 0025)
  • Advanced Medical Research Institute ( Site 0014)
  • Headlands Research Orlando ( Site 0031)
  • Genesis Clinical Research, LLC ( Site 0016)
  • Clinical Research Trials of Florida ( Site 0007)
  • Palm Beach Research Center ( Site 0060)
  • Clinical Research Prime ( Site 0010)
  • Solaris Clinical Research ( Site 0008)
  • Versailles Family Medicine / CCT Research ( Site 0063)
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038)
  • Alliance for Multispecialty Research, LLC ( Site 0026)
  • Skyline Medical Center/CCT Research ( Site 0028)
  • Methodist Physicians Clinic/CCT Research ( Site 0058)
  • Meridian Clinical Research, LLC ( Site 0045)
  • Healor Primary Care / CCT Research ( Site 0056)
  • Excel Clinical Research, LLC ( Site 0077)
  • Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029)
  • Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032)
  • Aventiv Research Inc ( Site 0044)
  • Advanced Medical Research ( Site 0002)
  • Lynn Institute of Norman ( Site 0001)
  • Lynn Health Science Institute ( Site 0005)
  • Lynn Institute of Tulsa ( Site 0084)
  • Summit Headlands ( Site 0047)
  • Velocity Clinical Research, Greenville ( Site 0043)
  • Trial Management Associates ( Site 0089)
  • Tekton Research, Inc. ( Site 0053)
  • WR-Global Medical Research, LLC ( Site 0065)
  • Elixir Research Group - W Houston ( Site 0068)
  • Epic Clinical Research ( Site 0082)
  • DCOL Center for Clinical Research ( Site 0051)
  • Research Your Health ( Site 0042)
  • IMA Clinical Research San Antonio ( Site 0009)
  • VIP Trials ( Site 0086)
  • Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036)
  • Olympus Family Medicine/CCT Research ( Site 0074)
  • South Ogden Family Medicine/ CCT Research ( Site 0022)
  • Charlottesville Medical Research ( Site 0034)
  • Health Research of Hampton Roads, Inc. ( Site 0004)
  • MultiCare Rockwood Cheney Clinic ( Site 0037)
  • Paratus Clinical Research Canberra ( Site 3000)
  • Emeritus Research ( Site 3004)
  • Paratus Clinical Research Central Coast ( Site 3001)
  • Westmead Hospital ( Site 3005)
  • Emeritus Research ( Site 3003)
  • Anima Diepenbeek ( Site 1003)
  • Private Practice - Dr. Martinot Jean-Benoit ( Site 1001)
  • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0504)
  • Universidad San Sebastian - Providencia ( Site 0514)
  • Espacio Eme ( Site 0509)
  • Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503)
  • InfektioResearch ( Site 1203)
  • Medizentrum Essen Borbeck ( Site 1200)
  • Universitaetsklinikum Koeln ( Site 1206)
  • Novopraxis Berlin GbR ( Site 1201)
  • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202)
  • Hamburger Institut fuer Therapieforschung GmbH ( Site 1204)
  • Gachon University Gil Medical Center ( Site 3205)
  • Korea University Ansan Hospital ( Site 3201)
  • The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 3206)
  • Ajou University Hospital-Department of Infectious Diseases ( Site 3209)
  • Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3207)
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3202)
  • Severance Hospital, Yonsei University Health System-Division of Infectious Diseases ( Site 3210)
  • Samsung Medical Center ( Site 3211)
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3203)
  • Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3204)
  • Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 3208)
  • Korea University Guro Hospital ( Site 3200)
  • Lakeland Clinical Trials ( Site 3102)
  • P3 Research - Tauranga ( Site 3100)
  • Southern Clinical Trials Ltd ( Site 3104)
  • Southern Clinical Trials Waitemata Ltd ( Site 3105)
  • P3 Research - Wellington ( Site 3101)
  • Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601)
  • San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606)
  • Clinical Research Investigator Group ( Site 0611)
  • Ponce School Of Medicine Caimed Center ( Site 0602)
  • Clinical Research Puerto Rico ( Site 0600)
  • ProbarE ( Site 1400)
  • CTC Karolinska ( Site 1405)
  • ProbarE i Stockholm AB ( Site 1401)
  • Studieenheten Akademiskt Specialistcentrum ( Site 1403)
  • CTC MTC ( Site 1404)
  • National Cheng Kung University Hospital ( Site 3301)
  • National Taiwan University Hospital ( Site 3300)
  • Taipei Medical University Hospital ( Site 3302)
  • Chang Gung Medical Foundation-Linkou Branch ( Site 3303)
  • Sakarya Training and Research Hospital ( Site 2205)
  • Hacettepe Universite Hastaneleri ( Site 2204)
  • Ankara City Hospital ( Site 2200)
  • Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Cohort 1 V116

Cohort 1 PCV20

Cohort 2 V116

Cohort 2 PCV20

Arm Description

Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.

Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.

Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.

Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.

Outcomes

Primary Outcome Measures

Percentage of participants with solicited injection-site adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of pain/tenderness, redness/erythema, and swelling.
Percentage of participants with solicited systemic AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of headache, muscle aches/myalgia, and tiredness/fatigue.
Percentage of participants with vaccine-related serious AE (SAE)
A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event.
Serotype specific opsonophagocytic (OPA) geometric mean titers (GMTs) in Cohorts 1 and 2 for the 21 serotypes contained in V116
The serotype specific OPA GMTs for the 21 serotypes contained in V116 will be determined using the multiplex opsonophagocytic assay (MOPA).
Percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs in Cohort 1 for the 21 serotypes contained in V116
The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 21 serotypes contained in V116 will be determined.

Secondary Outcome Measures

Percentage of participants with ≥4-fold rise in serotype specific cross-reactive OPA responses in Cohorts 1 and 2
The percentage of participants with ≥4-fold rise from baseline in serotype specific cross-reactive OPAs will be determined.
Serotype specific cross-reactive OPA GMTs in Cohorts 1 and 2
The serotype specific OPA GMTs will be determined using MOPA.
Serotype specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) in Cohort 1
The GMCs for serotype specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).
Geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs in Cohort 1
The GMFR from baseline in serotype specific OPA GMTs will be determined using MOPA.
GMFR from baseline in serotype specific IgG GMCs in Cohort 1
The GMFR in GMCs for serotype specific IgG antibodies will be determined using PnECL.
Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG GMCs in Cohort 1
The percentage of participants with ≥4-fold rise from baseline in GMCs for serotype specific IgG antibodies will be determined using PnECL.
Percentage of participants with ≥4-fold rise from baseline in serotype specific OPA GMTs in Cohort 1
The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs will be determined.

Full Information

First Posted
June 15, 2022
Last Updated
June 1, 2023
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT05425732
Brief Title
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
Official Title
A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
May 18, 2023 (Actual)
Study Completion Date
May 18, 2023 (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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2664 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 V116
Arm Type
Experimental
Arm Description
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
Arm Title
Cohort 1 PCV20
Arm Type
Active Comparator
Arm Description
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
Arm Title
Cohort 2 V116
Arm Type
Experimental
Arm Description
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
Arm Title
Cohort 2 PCV20
Arm Type
Active Comparator
Arm Description
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
Intervention Type
Biological
Intervention Name(s)
V116
Other Intervention Name(s)
Pneumococcal 21-valent Conjugate Vaccine
Intervention Description
0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.
Intervention Type
Biological
Intervention Name(s)
PCV20
Other Intervention Name(s)
Prevnar 20™, APEXXNAR™
Intervention Description
0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.
Primary Outcome Measure Information:
Title
Percentage of participants with solicited injection-site adverse events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of pain/tenderness, redness/erythema, and swelling.
Time Frame
Up to 5 days postvaccination
Title
Percentage of participants with solicited systemic AEs
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of headache, muscle aches/myalgia, and tiredness/fatigue.
Time Frame
Up to 5 days postvaccination
Title
Percentage of participants with vaccine-related serious AE (SAE)
Description
A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event.
Time Frame
Up to 194 days postvaccination
Title
Serotype specific opsonophagocytic (OPA) geometric mean titers (GMTs) in Cohorts 1 and 2 for the 21 serotypes contained in V116
Description
The serotype specific OPA GMTs for the 21 serotypes contained in V116 will be determined using the multiplex opsonophagocytic assay (MOPA).
Time Frame
Day 30 postvaccination
Title
Percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs in Cohort 1 for the 21 serotypes contained in V116
Description
The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 21 serotypes contained in V116 will be determined.
Time Frame
Baseline and Day 30 postvaccination
Secondary Outcome Measure Information:
Title
Percentage of participants with ≥4-fold rise in serotype specific cross-reactive OPA responses in Cohorts 1 and 2
Description
The percentage of participants with ≥4-fold rise from baseline in serotype specific cross-reactive OPAs will be determined.
Time Frame
Baseline and Day 30 postvaccination
Title
Serotype specific cross-reactive OPA GMTs in Cohorts 1 and 2
Description
The serotype specific OPA GMTs will be determined using MOPA.
Time Frame
Day 30 postvaccination
Title
Serotype specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) in Cohort 1
Description
The GMCs for serotype specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).
Time Frame
Day 30 postvaccination
Title
Geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs in Cohort 1
Description
The GMFR from baseline in serotype specific OPA GMTs will be determined using MOPA.
Time Frame
Baseline and Day 30 postvaccination
Title
GMFR from baseline in serotype specific IgG GMCs in Cohort 1
Description
The GMFR in GMCs for serotype specific IgG antibodies will be determined using PnECL.
Time Frame
Baseline and Day 30 postvaccination
Title
Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG GMCs in Cohort 1
Description
The percentage of participants with ≥4-fold rise from baseline in GMCs for serotype specific IgG antibodies will be determined using PnECL.
Time Frame
Baseline and Day 30 postvaccination
Title
Percentage of participants with ≥4-fold rise from baseline in serotype specific OPA GMTs in Cohort 1
Description
The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs will be determined.
Time Frame
Baseline and Day 30 postvaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of an early undetected pregnancy. Exclusion Criteria: Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1) Has a known hypersensitivity to any component of V116 or PCV20, including diphtheria toxoid Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease Has a coagulation disorder contraindicating IM vaccination Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine Has a known malignancy that is progressing or has required active treatment <3 years before enrollment Received prior administration (prior to age of 5 is acceptable) of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable) Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete
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
Central Research Associates ( Site 0067)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Lenzmeier Family Medicine/CCT Research ( Site 0006)
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Desert Clinical Research/ CCT Research ( Site 0040)
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Foothills Research Center/ CCT Research ( Site 0021)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003)
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Baptist Health Center For Clinical Research ( Site 0019)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southland Clinical Research Center-Research ( Site 0054)
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Sunwise Clinical Research ( Site 0024)
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Chemidox Clinical Trials ( Site 0048)
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc ( Site 0018)
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Peninsula Research Associates ( Site 0079)
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Acclaim Clinical Research ( Site 0083)
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Millennium Clinical Trials ( Site 0013)
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Lynn Institute of Denver ( Site 0012)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc ( Site 0027)
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
JEM Research Institute ( Site 0072)
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0015)
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Hillcrest Medical Research ( Site 0049)
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
East Coast Institute for Research, LLC ( Site 0070)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
East Coast Institute for Research ( Site 0071)
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
L&C Professional Medical Research Institute ( Site 0025)
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Advanced Medical Research Institute ( Site 0014)
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Headlands Research Orlando ( Site 0031)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Genesis Clinical Research, LLC ( Site 0016)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Clinical Research Trials of Florida ( Site 0007)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Palm Beach Research Center ( Site 0060)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Clinical Research Prime ( Site 0010)
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Solaris Clinical Research ( Site 0008)
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Versailles Family Medicine / CCT Research ( Site 0063)
City
Versailles
State/Province
Kentucky
ZIP/Postal Code
40383
Country
United States
Facility Name
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038)
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0026)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Skyline Medical Center/CCT Research ( Site 0028)
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Methodist Physicians Clinic/CCT Research ( Site 0058)
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Meridian Clinical Research, LLC ( Site 0045)
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Healor Primary Care / CCT Research ( Site 0056)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Excel Clinical Research, LLC ( Site 0077)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032)
City
Horseheads
State/Province
New York
ZIP/Postal Code
14845
Country
United States
Facility Name
Aventiv Research Inc ( Site 0044)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Advanced Medical Research ( Site 0002)
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Lynn Institute of Norman ( Site 0001)
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Lynn Health Science Institute ( Site 0005)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Lynn Institute of Tulsa ( Site 0084)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Summit Headlands ( Site 0047)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Velocity Clinical Research, Greenville ( Site 0043)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Trial Management Associates ( Site 0089)
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Tekton Research, Inc. ( Site 0053)
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
WR-Global Medical Research, LLC ( Site 0065)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Facility Name
Elixir Research Group - W Houston ( Site 0068)
City
Houston
State/Province
Texas
ZIP/Postal Code
77077
Country
United States
Facility Name
Epic Clinical Research ( Site 0082)
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
Facility Name
DCOL Center for Clinical Research ( Site 0051)
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Research Your Health ( Site 0042)
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
IMA Clinical Research San Antonio ( Site 0009)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
VIP Trials ( Site 0086)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036)
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Olympus Family Medicine/CCT Research ( Site 0074)
City
Holladay
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
South Ogden Family Medicine/ CCT Research ( Site 0022)
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Charlottesville Medical Research ( Site 0034)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Health Research of Hampton Roads, Inc. ( Site 0004)
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
MultiCare Rockwood Cheney Clinic ( Site 0037)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Paratus Clinical Research Canberra ( Site 3000)
City
Bruce
State/Province
Australian Capital Territory
ZIP/Postal Code
2617
Country
Australia
Facility Name
Emeritus Research ( Site 3004)
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Facility Name
Paratus Clinical Research Central Coast ( Site 3001)
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Westmead Hospital ( Site 3005)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Emeritus Research ( Site 3003)
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Anima Diepenbeek ( Site 1003)
City
Diepenbeek
State/Province
Limburg
ZIP/Postal Code
3590
Country
Belgium
Facility Name
Private Practice - Dr. Martinot Jean-Benoit ( Site 1001)
City
Erpent
State/Province
Namur
ZIP/Postal Code
5101
Country
Belgium
Facility Name
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0504)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Universidad San Sebastian - Providencia ( Site 0514)
City
Providencia
State/Province
Region M. De Santiago
ZIP/Postal Code
7500000
Country
Chile
Facility Name
Espacio Eme ( Site 0509)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7770086
Country
Chile
Facility Name
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330034
Country
Chile
Facility Name
InfektioResearch ( Site 1203)
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Medizentrum Essen Borbeck ( Site 1200)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Universitaetsklinikum Koeln ( Site 1206)
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novopraxis Berlin GbR ( Site 1201)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Hamburger Institut fuer Therapieforschung GmbH ( Site 1204)
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Gachon University Gil Medical Center ( Site 3205)
City
Namdong-gu
State/Province
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital ( Site 3201)
City
Ansan-si
State/Province
Kyonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 3206)
City
Suwon-si
State/Province
Kyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Ajou University Hospital-Department of Infectious Diseases ( Site 3209)
City
Suwon-si
State/Province
Kyonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3207)
City
Deagu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3202)
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System-Division of Infectious Diseases ( Site 3210)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 3211)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3203)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3204)
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 3208)
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 3200)
City
Seoul
Country
Korea, Republic of
Facility Name
Lakeland Clinical Trials ( Site 3102)
City
Rotorua
State/Province
Bay Of Plenty
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
P3 Research - Tauranga ( Site 3100)
City
Tauranga
State/Province
Bay Of Plenty
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
Southern Clinical Trials Ltd ( Site 3104)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Southern Clinical Trials Waitemata Ltd ( Site 3105)
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
P3 Research - Wellington ( Site 3101)
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601)
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606)
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Clinical Research Investigator Group ( Site 0611)
City
Canovanas
ZIP/Postal Code
00729
Country
Puerto Rico
Facility Name
Ponce School Of Medicine Caimed Center ( Site 0602)
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico ( Site 0600)
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
ProbarE ( Site 1400)
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
222 22
Country
Sweden
Facility Name
CTC Karolinska ( Site 1405)
City
Solna
State/Province
Stockholms Lan
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
ProbarE i Stockholm AB ( Site 1401)
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
113 29
Country
Sweden
Facility Name
Studieenheten Akademiskt Specialistcentrum ( Site 1403)
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
113 61
Country
Sweden
Facility Name
CTC MTC ( Site 1404)
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
752 37
Country
Sweden
Facility Name
National Cheng Kung University Hospital ( Site 3301)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 3300)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Medical University Hospital ( Site 3302)
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-Linkou Branch ( Site 3303)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Sakarya Training and Research Hospital ( Site 2205)
City
Adapazarı
State/Province
Sakarya
ZIP/Postal Code
54100
Country
Turkey
Facility Name
Hacettepe Universite Hastaneleri ( Site 2204)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Ankara City Hospital ( Site 2200)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201)
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey

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

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

We'll reach out to this number within 24 hrs