Back to resultsA Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
Primary Purpose
Pneumococcal Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V116
PPSV23
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Disease
Eligibility Criteria
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- Has underlying chronic conditions but assessed to be stable as per investigator
- Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator
Exclusion Criteria:
- Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
- Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
- Has a coagulation disorder contraindicating intramuscular vaccination
- Has a recent illness with fever
- Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
- Is expected to receive any pneumococcal vaccine during the study outside of the protocol
- Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥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
- Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine
- Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
- Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
Sites / Locations
- Desert Clinical Research/ CCT Research ( Site 0019)
- Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008)
- Baptist Health Center For Clinical Research ( Site 0015)
- Valley Clinical Trials, Inc. ( Site 0023)
- Artemis Institute for Clinical Research ( Site 0027)
- Millennium Clinical Trials ( Site 0004)
- Diablo Clinical Research, Inc. ( Site 0022)
- Lynn Institute of Denver ( Site 0003)
- Indago Research & Health Center, Inc ( Site 0011)
- L&C Professional Medical Research Institute ( Site 0012)
- Headlands Research Orlando ( Site 0017)
- Clinical Research Trials of Florida ( Site 0001)
- Clinical Research Prime Rexburg ( Site 0040)
- Healthcare Research Network - Chicago ( Site 0006)
- Kentucky Pediatric/ Adult Research ( Site 0036)
- Alliance for Multispecialty Research, LLC ( Site 0031)
- Methodist Physicians Clinic/CCT Research ( Site 0029)
- Healor Primary Care / CCT Research ( Site 0028)
- Axces Research ( Site 0034)
- Rochester Clinical Research, Inc. ( Site 0033)
- M3 Wake Research Associates ( Site 0035)
- Lynn Health Science Institute ( Site 0014)
- Velocity Clinical Research, Providence ( Site 0018)
- Velocity Clinical Research, Greenville ( Site 0021)
- Clinical Research Associates Inc ( Site 0039)
- DCOL Center for Clinical Research ( Site 0025)
- IMA Clinical Research San Antonio ( Site 0020)
- Dynamed Clinical Research, LP d/b/a DM Clinical Research ( Site 0016)
- Charlottesville Medical Research ( Site 0013)
- Health Research of Hampton Roads, Inc. ( Site 0002)
- Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 0304)
- Medizinische Universitaet Innsbruck ( Site 0301)
- Tropeninstitut Wien 1060 ( Site 0300)
- Medizinische Universität Wien ( Site 0302)
- Colchester Research Group ( Site 0202)
- Hamilton Medical Research Group ( Site 0208)
- Milestone Research Inc. ( Site 0201)
- Manna Research Toronto ( Site 0209)
- Manna Research Mirabel ( Site 0207)
- Manna Research Montreal ( Site 0203)
- Q&T Research Sherbrooke Inc. ( Site 0204)
- Diex Recherche Trois-Rivieres ( Site 0206)
- Sanos Clinic-Sanos Clinic ( Site 0402)
- Danske Lægers Vaccinations Service - Søborg ( Site 0404)
- Danske Lægers Vaccinations Service - Århus ( Site 0403)
- Sanos Clinic - Nordjylland ( Site 0401)
- Sanos Clinic - Syddanmark ( Site 0400)
- FVR, Oulun rokotetutkimusklinikka ( Site 0501)
- FVR, Porin rokotetutkimusklinikka ( Site 0508)
- FVR, Seinäjoen rokotetutkimusklinikka ( Site 0504)
- FVR, Espoon rokotetutkimusklinikka ( Site 0509)
- FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0503)
- Helsinki East Vaccine Research Clinic ( Site 0502)
- FVR, Turun rokotetutkimusklinikka ( Site 0500)
- Rambam Health Care Campus ( Site 0603)
- Maccabi Healthcare Services ( Site 0606)
- Hadassah Medical Center ( Site 0600)
- Meir Medical Center ( Site 0601)
- Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0604)
- Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0602)
- IN VIVO ( Site 0711)
- Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0709)
- MICS Centrum Medyczne Torun ( Site 0706)
- Clinmedica OMC ( Site 0701)
- Alergotest s.c Specjalistyczne Centrum Medyczne ( Site 0703)
- Centrum Medyczne Medyk ( Site 0704)
- EBA CENTELLES ( Site 0800)
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0808)
- Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 0818)
- Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 0801)
- EAP Sardenya ( Site 0802)
- Hospital La Princesa-Clinical Pharmacology ( Site 0815)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
V116 Lot 1
V116 Lot 2
V116 Lot 3
PPSV23
Arm Description
Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.
Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1.
Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1.
Participants will receive a single 0.5 mL IM dose of PPSV23 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 include 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 include headache, muscle aches/myalgia, and tiredness/fatigue.
Percentage of participants with vaccine-related serious adverse events (SAEs)
An SAE is any untoward medical occurrence that, at any dose, 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 another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination will be summarized.
Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) for all serotypes in V116 following vaccination with 1 of 3 different lots of V116
Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using multiplex opsonophagocytic assay (MOPA).
Secondary Outcome Measures
GMTs of serotype-specific OPA for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™
Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using MOPA.
Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) for all serotypes in V116 following vaccination with separate V116 lots
Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using pneumococcal electrochemiluminescence (PnECL).
GMCs of serotype-specific IgG for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™
Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using PnECL.
Geometric mean fold rise (GMFR) in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots
Serotype-specific OPA GMFR for all serotypes in V116 following vaccination will be determined using MOPA.
Percentage of participants with ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots
Percentage of participants with a ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination will be reported.
GMFR in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots
Serotype-specific IgG GMFR for all serotypes in V116 following vaccination will be determined using PnECL.
Percentage of participants with ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots
Percentage of participants with a ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination will be reported.
GMTs of serotype-specific OPA for cross-reactive serotypes following vaccination with separate V116 Lots
Serotype-specific OPA GMTs for cross-reactive serotypes following vaccination will be determined using MOPA.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05464420
Brief Title
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
Official Title
A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
May 25, 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 study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.
The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
V116 Lot 1
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.
Arm Title
V116 Lot 2
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1.
Arm Title
V116 Lot 3
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1.
Arm Title
PPSV23
Arm Type
Active Comparator
Arm Description
Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.
Intervention Type
Biological
Intervention Name(s)
V116
Other Intervention Name(s)
Pneumococcal 21-valent Conjugate Vaccine
Intervention Description
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Intervention Type
Biological
Intervention Name(s)
PPSV23
Other Intervention Name(s)
PNEUMOVAX™23
Intervention Description
Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
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 include pain/tenderness, redness/erythema, and swelling.
Time Frame
Up to ~5 days
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 include headache, muscle aches/myalgia, and tiredness/fatigue.
Time Frame
Up to ~5 days
Title
Percentage of participants with vaccine-related serious adverse events (SAEs)
Description
An SAE is any untoward medical occurrence that, at any dose, 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 another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination will be summarized.
Time Frame
Up to ~6 months
Title
Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) for all serotypes in V116 following vaccination with 1 of 3 different lots of V116
Description
Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using multiplex opsonophagocytic assay (MOPA).
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
GMTs of serotype-specific OPA for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™
Description
Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using MOPA.
Time Frame
Day 30
Title
Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) for all serotypes in V116 following vaccination with separate V116 lots
Description
Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using pneumococcal electrochemiluminescence (PnECL).
Time Frame
Day 30
Title
GMCs of serotype-specific IgG for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™
Description
Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using PnECL.
Time Frame
Day 30
Title
Geometric mean fold rise (GMFR) in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots
Description
Serotype-specific OPA GMFR for all serotypes in V116 following vaccination will be determined using MOPA.
Time Frame
Baseline (Day 1) and Day 30
Title
Percentage of participants with ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots
Description
Percentage of participants with a ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination will be reported.
Time Frame
Baseline (Day 1) and Day 30
Title
GMFR in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots
Description
Serotype-specific IgG GMFR for all serotypes in V116 following vaccination will be determined using PnECL.
Time Frame
Baseline (Day 1) and Day 30
Title
Percentage of participants with ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots
Description
Percentage of participants with a ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination will be reported.
Time Frame
Baseline (Day 1) and Day 30
Title
GMTs of serotype-specific OPA for cross-reactive serotypes following vaccination with separate V116 Lots
Description
Serotype-specific OPA GMTs for cross-reactive serotypes following vaccination will be determined using MOPA.
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Has underlying chronic conditions but assessed to be stable as per investigator
Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator
Exclusion Criteria:
Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
Has a coagulation disorder contraindicating intramuscular vaccination
Has a recent illness with fever
Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
Is expected to receive any pneumococcal vaccine during the study outside of the protocol
Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥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
Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine
Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
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
Desert Clinical Research/ CCT Research ( Site 0019)
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008)
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Baptist Health Center For Clinical Research ( Site 0015)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Valley Clinical Trials, Inc. ( Site 0023)
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Artemis Institute for Clinical Research ( Site 0027)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Millennium Clinical Trials ( Site 0004)
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Diablo Clinical Research, Inc. ( Site 0022)
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Lynn Institute of Denver ( Site 0003)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Indago Research & Health Center, Inc ( Site 0011)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
L&C Professional Medical Research Institute ( Site 0012)
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Headlands Research Orlando ( Site 0017)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Clinical Research Trials of Florida ( Site 0001)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Clinical Research Prime Rexburg ( Site 0040)
City
Rexburg
State/Province
Idaho
ZIP/Postal Code
83440
Country
United States
Facility Name
Healthcare Research Network - Chicago ( Site 0006)
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Kentucky Pediatric/ Adult Research ( Site 0036)
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0031)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Methodist Physicians Clinic/CCT Research ( Site 0029)
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Healor Primary Care / CCT Research ( Site 0028)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Axces Research ( Site 0034)
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Rochester Clinical Research, Inc. ( Site 0033)
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
M3 Wake Research Associates ( Site 0035)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Lynn Health Science Institute ( Site 0014)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Velocity Clinical Research, Providence ( Site 0018)
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Velocity Clinical Research, Greenville ( Site 0021)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Clinical Research Associates Inc ( Site 0039)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
DCOL Center for Clinical Research ( Site 0025)
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
IMA Clinical Research San Antonio ( Site 0020)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dynamed Clinical Research, LP d/b/a DM Clinical Research ( Site 0016)
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Charlottesville Medical Research ( Site 0013)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Health Research of Hampton Roads, Inc. ( Site 0002)
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 0304)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universitaet Innsbruck ( Site 0301)
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Tropeninstitut Wien 1060 ( Site 0300)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
Medizinische Universität Wien ( Site 0302)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Colchester Research Group ( Site 0202)
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
Hamilton Medical Research Group ( Site 0208)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Milestone Research Inc. ( Site 0201)
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Manna Research Toronto ( Site 0209)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Manna Research Mirabel ( Site 0207)
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Manna Research Montreal ( Site 0203)
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Q&T Research Sherbrooke Inc. ( Site 0204)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
Diex Recherche Trois-Rivieres ( Site 0206)
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 4P3
Country
Canada
Facility Name
Sanos Clinic-Sanos Clinic ( Site 0402)
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Danske Lægers Vaccinations Service - Søborg ( Site 0404)
City
Soborg
State/Province
Hovedstaden
ZIP/Postal Code
2860
Country
Denmark
Facility Name
Danske Lægers Vaccinations Service - Århus ( Site 0403)
City
Aarhus
State/Province
Midtjylland
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Sanos Clinic - Nordjylland ( Site 0401)
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9362
Country
Denmark
Facility Name
Sanos Clinic - Syddanmark ( Site 0400)
City
Vejle
State/Province
Syddanmark
ZIP/Postal Code
7100
Country
Denmark
Facility Name
FVR, Oulun rokotetutkimusklinikka ( Site 0501)
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Facility Name
FVR, Porin rokotetutkimusklinikka ( Site 0508)
City
Pori
State/Province
Satakunta
ZIP/Postal Code
28100
Country
Finland
Facility Name
FVR, Seinäjoen rokotetutkimusklinikka ( Site 0504)
City
Seinajoki
State/Province
Sodra Osterbotten
ZIP/Postal Code
60100
Country
Finland
Facility Name
FVR, Espoon rokotetutkimusklinikka ( Site 0509)
City
Espoo
State/Province
Uusimaa
ZIP/Postal Code
02230
Country
Finland
Facility Name
FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0503)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00100
Country
Finland
Facility Name
Helsinki East Vaccine Research Clinic ( Site 0502)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00930
Country
Finland
Facility Name
FVR, Turun rokotetutkimusklinikka ( Site 0500)
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20520
Country
Finland
Facility Name
Rambam Health Care Campus ( Site 0603)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Maccabi Healthcare Services ( Site 0606)
City
Jerusalem
ZIP/Postal Code
71713
Country
Israel
Facility Name
Hadassah Medical Center ( Site 0600)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center ( Site 0601)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0604)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0602)
City
Sakhnin
ZIP/Postal Code
3081000
Country
Israel
Facility Name
IN VIVO ( Site 0711)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-048
Country
Poland
Facility Name
Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0709)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
MICS Centrum Medyczne Torun ( Site 0706)
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Clinmedica OMC ( Site 0701)
City
Skierniewice
State/Province
Lodzkie
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Alergotest s.c Specjalistyczne Centrum Medyczne ( Site 0703)
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-095
Country
Poland
Facility Name
Centrum Medyczne Medyk ( Site 0704)
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-055
Country
Poland
Facility Name
EBA CENTELLES ( Site 0800)
City
Centelles
State/Province
Cataluna
ZIP/Postal Code
08500
Country
Spain
Facility Name
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0808)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 0818)
City
València
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46015
Country
Spain
Facility Name
Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 0801)
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
EAP Sardenya ( Site 0802)
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital La Princesa-Clinical Pharmacology ( Site 0815)
City
Madrid
ZIP/Postal Code
28006
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
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
We'll reach out to this number within 24 hrs