Back to resultsA Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
Primary Purpose
Pneumonia, Pneumococcal
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
V116
QIV
Matching Placebo for V116
Sponsored by
About this trial
This is an interventional prevention trial for Pneumonia, Pneumococcal
Eligibility Criteria
Inclusion Criteria:
- Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent
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
- Has a known hypersensitivity to any component of V116 or any influenza vaccine, 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 intramuscular vaccination
- 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
- Received any pneumococcal vaccine <12 months prior to enrollment (including pneumococcal 13-valent conjugate vaccine [PCV13] followed by pneumococcal 23-valent polysaccharide vaccine [PPSV23] and PPSV23 followed by PCV13)
- Had prior administration of PCV15 or PCV20
- Received any influenza vaccine <6 months prior to enrollment or is expected to receive any influenza vaccine during the study outside of 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
- 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 before the Day 30 postvaccination blood draw is complete
- Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study
Sites / Locations
- Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012)
- Hope Clinical Research, Inc. ( Site 0070)
- Paradigm Clinical Research Centers, Inc ( Site 0024)
- Catalina Research Institute, LLC ( Site 0067)
- WR- PRI, LLC ( Site 0044)
- Carbon Health - North Hollywood - NoHo West ( Site 0016)
- Valley Clinical Trials, Inc. ( Site 0002)
- Artemis Institute for Clinical Research ( Site 0023)
- WR-MCCR, LLC ( Site 0033)
- California Research Foundation ( Site 0005)
- Diablo Clinical Research, Inc. ( Site 0020)
- Velocity Clinical Research, Hallandale Beach ( Site 0064)
- Indago Research & Health Center, Inc ( Site 0029)
- East Coast Institute for Research, LLC ( Site 0013)
- Health Awareness ( Site 0034)
- Optimal Research ( Site 0008)
- Lakes Research ( Site 0063)
- Suncoast Research Group-Clinical Department ( Site 0062)
- Suncoast Research Associates ( Site 0041)
- Alpha Science Research ( Site 0042)
- Triple O Research Institute, P.A ( Site 0054)
- East Coast Institute for Research - Canton ( Site 0004)
- Clinical Research Atlanta ( Site 0068)
- Synexus Clinical Research US, Inc. ( Site 0072)
- Healthcare Research Network - Chicago ( Site 0014)
- Centennial Medical Group ( Site 0035)
- Healthcare Research Network - St. Louis ( Site 0011)
- Radiant Research ( Site 0073)
- Alivation Research-Primary Care ( Site 0066)
- WR-CRCN, LLC ( Site 0018)
- Axces Research ( Site 0037)
- Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019)
- Synexus Clinical Research US, Inc - New York ( Site 0053)
- Rochester Clinical Research, Inc. ( Site 0055)
- Meridian Clinical Research, LLC ( Site 0032)
- Carolina Institute for Clinical Research ( Site 0047)
- M3 Wake Research Associates ( Site 0040)
- CTI Clinical Research Center ( Site 0071)
- Velocity Clinical Research, Medford ( Site 0060)
- Hatboro Medical Associates / CCT Research ( Site 0065)
- Velocity Clinical Research, Providence ( Site 0021)
- Velocity Clinical Research, Anderson ( Site 0077)
- Velocity Clinical Research, Columbia ( Site 0058)
- Holston Medical Group-Clinical Research ( Site 0028)
- Holston Medical Group-Clinical Research ( Site 0009)
- Clinical Research Associates Inc ( Site 0026)
- Optimal Research ( Site 0015)
- Headlands Research - Brownsville ( Site 0069)
- Benchmark Research ( Site 0025)
- New Horizon Medical Group ( Site 0078)
- Innovative Medical Research of Texas ( Site 0079)
- LinQ Research ( Site 0074)
- Synexus Clinical Research US, Inc. ( Site 0001)
- Alliance for Multispecialty Research, LLC ( Site 0051)
- Arthritis Northwest, PLLC ( Site 0059)
- Velocity Clinical Research, Spokane ( Site 0050)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Concomitant group (V116 + QIV followed by placebo)
Sequential group (placebo + QIV followed by V116)
Arm Description
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30
Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30
Outcomes
Primary Outcome Measures
Percentage of Participants with Solicited Injection-site Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs include tenderness/injection-site pain, injection-site redness/injection-site erythema, and injection-site swelling/injection-site swelling.
Percentage of Participants with Solicited Systemic AEs
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs include muscle aches all over body/myalgia, headache, and tiredness/fatigue.
Percentage of Participants with Vaccine-related Serious Adverse Events (SAEs)
A serious adverse event (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 Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA).
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay
Secondary Outcome Measures
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
The GMC of serotype-specific IgG for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an pneumococcal electrochemiluminescence (Pn ECL) assay.
Geometric Mean Fold Rise (GMFR) of Serotype-specific OPA
Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Geometric Mean Fold Rise (GMFR) of Serotype-specific IgG
Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an Pn ECL assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
GMFR in Influenza Strain-specific HAI
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.
Percentage of Participants with Influenza Strain-specific HAI Titer ≥1:40
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05526716
Brief Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
Official Title
A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
June 21, 2023 (Actual)
Study Completion Date
June 21, 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 a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumococcal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1080 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concomitant group (V116 + QIV followed by placebo)
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30
Arm Title
Sequential group (placebo + QIV followed by V116)
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30
Intervention Type
Biological
Intervention Name(s)
V116
Intervention Description
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the 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)
QIV
Intervention Description
Single 0.5 mL IM injection
Intervention Type
Biological
Intervention Name(s)
Matching Placebo for V116
Intervention Description
Single 0.5 mL of sterile saline IM injection
Primary Outcome Measure Information:
Title
Percentage of Participants with Solicited Injection-site Adverse Events (AEs)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs include tenderness/injection-site pain, injection-site redness/injection-site erythema, and injection-site swelling/injection-site swelling.
Time Frame
Up to 5 days post-vaccination
Title
Percentage of Participants with Solicited Systemic AEs
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs include muscle aches all over body/myalgia, headache, and tiredness/fatigue.
Time Frame
Up to 5 days post-vaccination
Title
Percentage of Participants with Vaccine-related Serious Adverse Events (SAEs)
Description
A serious adverse event (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 ~210 days
Title
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
Description
Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA).
Time Frame
30 days after V116 vaccination (Day 30 for concomitant group and Day 60 for sequential group)
Title
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)
Description
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Description
The GMC of serotype-specific IgG for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an pneumococcal electrochemiluminescence (Pn ECL) assay.
Time Frame
30 days after V116 vaccination (Day 30 for concomitant group and Day 60 for sequential group)
Title
Geometric Mean Fold Rise (GMFR) of Serotype-specific OPA
Description
Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time Frame
Day 1 (Baseline) and Day 30 post-vaccination for concomitant group. Day 1 (Baseline) and Day 60 post-vaccination for sequential group.
Title
Geometric Mean Fold Rise (GMFR) of Serotype-specific IgG
Description
Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an Pn ECL assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time Frame
Day 1 (Baseline) and Day 30 post-vaccination for concomitant group. Day 1 (Baseline) and Day 60 post-vaccination for sequential group.
Title
GMFR in Influenza Strain-specific HAI
Description
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.
Time Frame
Day 1 (Baseline) and Day 30
Title
Percentage of Participants with Influenza Strain-specific HAI Titer ≥1:40
Description
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.
Time Frame
Day 30
Title
Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI
Description
Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent
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
Has a known hypersensitivity to any component of V116 or any influenza vaccine, 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 intramuscular vaccination
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
Received any pneumococcal vaccine <12 months prior to enrollment (including pneumococcal 13-valent conjugate vaccine [PCV13] followed by pneumococcal 23-valent polysaccharide vaccine [PPSV23] and PPSV23 followed by PCV13)
Had prior administration of PCV15 or PCV20
Received any influenza vaccine <6 months prior to enrollment or is expected to receive any influenza vaccine during the study outside of 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
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 before the Day 30 postvaccination blood draw is complete
Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study
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 Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Hope Clinical Research, Inc. ( Site 0070)
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc ( Site 0024)
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Catalina Research Institute, LLC ( Site 0067)
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
WR- PRI, LLC ( Site 0044)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92620
Country
United States
Facility Name
Carbon Health - North Hollywood - NoHo West ( Site 0016)
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Valley Clinical Trials, Inc. ( Site 0002)
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Artemis Institute for Clinical Research ( Site 0023)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
WR-MCCR, LLC ( Site 0033)
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
California Research Foundation ( Site 0005)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Diablo Clinical Research, Inc. ( Site 0020)
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach ( Site 0064)
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Indago Research & Health Center, Inc ( Site 0029)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
East Coast Institute for Research, LLC ( Site 0013)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Health Awareness ( Site 0034)
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Optimal Research ( Site 0008)
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Lakes Research ( Site 0063)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Suncoast Research Group-Clinical Department ( Site 0062)
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Suncoast Research Associates ( Site 0041)
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Alpha Science Research ( Site 0042)
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Triple O Research Institute, P.A ( Site 0054)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
East Coast Institute for Research - Canton ( Site 0004)
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
Facility Name
Clinical Research Atlanta ( Site 0068)
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Synexus Clinical Research US, Inc. ( Site 0072)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Healthcare Research Network - Chicago ( Site 0014)
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Centennial Medical Group ( Site 0035)
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Healthcare Research Network - St. Louis ( Site 0011)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Radiant Research ( Site 0073)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Alivation Research-Primary Care ( Site 0066)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
WR-CRCN, LLC ( Site 0018)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Axces Research ( Site 0037)
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019)
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Synexus Clinical Research US, Inc - New York ( Site 0053)
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Rochester Clinical Research, Inc. ( Site 0055)
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Meridian Clinical Research, LLC ( Site 0032)
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Carolina Institute for Clinical Research ( Site 0047)
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
M3 Wake Research Associates ( Site 0040)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
CTI Clinical Research Center ( Site 0071)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Velocity Clinical Research, Medford ( Site 0060)
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Hatboro Medical Associates / CCT Research ( Site 0065)
City
Hatboro
State/Province
Pennsylvania
ZIP/Postal Code
19040
Country
United States
Facility Name
Velocity Clinical Research, Providence ( Site 0021)
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Velocity Clinical Research, Anderson ( Site 0077)
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Velocity Clinical Research, Columbia ( Site 0058)
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Holston Medical Group-Clinical Research ( Site 0028)
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group-Clinical Research ( Site 0009)
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Clinical Research Associates Inc ( Site 0026)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Optimal Research ( Site 0015)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Headlands Research - Brownsville ( Site 0069)
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78526
Country
United States
Facility Name
Benchmark Research ( Site 0025)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
New Horizon Medical Group ( Site 0078)
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States
Facility Name
Innovative Medical Research of Texas ( Site 0079)
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
LinQ Research ( Site 0074)
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Synexus Clinical Research US, Inc. ( Site 0001)
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0051)
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Arthritis Northwest, PLLC ( Site 0059)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Velocity Clinical Research, Spokane ( Site 0050)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
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, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
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