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Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

Primary Purpose

Pneumococcal Disease

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V116
PPSV23
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

50 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 inclusion 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 PPSV23, 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 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

  • Fundacion Estudios Clinicos ( Site 0200)
  • Paratus Clinical Research Western Sydney ( Site 1500)
  • Northern Beaches Clinical Research ( Site 1502)
  • Paratus Clinical Research Brisbane ( Site 1501)
  • IPS Centro Científico Asistencial S.A.S ( Site 0407)
  • Fundacion Valle del Lili- CIC ( Site 0415)
  • klinikum rechts der isar der technischen universität münchen ( Site 0904)
  • InfektioResearch ( Site 0903)
  • Medizentrum Essen Borbeck ( Site 0902)
  • Universitaetsklinikum Koeln ( Site 0900)
  • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901)
  • Rambam Health Care Campus ( Site 1002)
  • Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004)
  • Meir Medical Center-Infectious unit ( Site 1003)
  • Sheba Medical Center ( Site 1000)
  • Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1001)
  • Wonju Severance Christian Hospital ( Site 1808)
  • Chonnam National University Hospital-Infectious Diseases ( Site 1811)
  • Korea University Ansan Hospital ( Site 1801)
  • Soon Chun Hyang University Bucheon Hospital ( Site 1812)
  • Hallym University Dongtan Sacred Heart Hospital ( Site 1813)
  • The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 1803)
  • Dong-A University Hospital ( Site 1810)
  • Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 1804)
  • Chungnam national university hospital ( Site 1814)
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 1802)
  • Asan Medical Center ( Site 1809)
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1806)
  • Hallym University Kangnam Sacred Heart Hospital ( Site 1807)
  • Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 1805)
  • Korea University Guro Hospital ( Site 1800)
  • P3 Research - Palmerston North ( Site 1602)
  • P3 Research - Lower Hutt ( Site 1601)
  • Optimal Clinical Trials ( Site 1600)
  • EBA CENTELLES ( Site 1100)
  • Hospital Universitario Getafe ( Site 1111)
  • Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118)
  • Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 1101)
  • EAP Sardenya ( Site 1102)
  • Hospital La Princesa-Clinical Pharmacology ( Site 1115)
  • Kaohsiung Medical University Chung-Ho Memorial Hospital-Infectious diseases Division, Department of
  • National Cheng Kung University Hospital ( Site 1901)
  • National Taiwan University Hospital ( Site 1900)
  • Chang Gung Medical Foundation-Linkou Branch ( Site 1902)
  • Sancaktepe Şehit Prof.Dr. İlhan Varank Eğitim ve Arastirma Hastanesi ( Site 1305)
  • ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304)
  • Hacettepe Universite Hastaneleri-İnfection ( Site 1300)
  • Gazi University Health Research and Application Center Gazi Hospital-Enfeksiyon Hastalıkları ( Site
  • Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301)
  • Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405)
  • Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 1407)
  • Royal Free Hospital-Ian Charleson Day Centre RESEARCH ( Site 1402)
  • Layton Medical Centre ( Site 1400)
  • Accellacare - Northamptonshire ( Site 1403)
  • Accellacare - Warwickshire ( Site 1404)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

V116 Treatment

PPSV23 Treatment

Arm Description

Participants receive a single intramuscular (IM) injection of V116 on Day 1.

Participants receive a single IM injection of PPSV23 on Day 1.

Outcomes

Primary Outcome Measures

Percentage of participants with solicited injection-site 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 muscle aches all over body/myalgia, headache, and tiredness/fatigue.
Percentage of participants with vaccine-related serious AE (SAE)
An SAE is any untoward medical occurrence 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. SAEs that were reported to be at least possibly related by the investigator to study vaccination will be summarized.
Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs)
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 (unique to V116)
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the unique serotypes contained in V116 will be determined.

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2022
Last Updated
October 23, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05569954
Brief Title
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)
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 50 Years of Age or Older
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
April 2, 2025 (Anticipated)

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
Product Manufactured in and Exported from the U.S.
Yes
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 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).

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
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V116 Treatment
Arm Type
Experimental
Arm Description
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
Arm Title
PPSV23 Treatment
Arm Type
Active Comparator
Arm Description
Participants receive a single IM injection of PPSV23 on Day 1.
Intervention Type
Biological
Intervention Name(s)
V116
Other Intervention Name(s)
Pneumococcal 21-valent Conjugate Vaccine
Intervention Description
Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B.
Intervention Type
Biological
Intervention Name(s)
PPSV23
Other Intervention Name(s)
PNEUMOVAX™23
Intervention Description
Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each 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.
Primary Outcome Measure Information:
Title
Percentage of participants with solicited injection-site 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 muscle aches all over body/myalgia, headache, and tiredness/fatigue.
Time Frame
Up to 5 days postvaccination
Title
Percentage of participants with vaccine-related serious AE (SAE)
Description
An SAE is any untoward medical occurrence 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. 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 postvaccination
Title
Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs)
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 (unique to V116)
Description
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the unique serotypes contained in V116 will be determined.
Time Frame
Baseline (Day 1) and Day 30 postvaccination
Secondary Outcome Measure Information:
Title
Percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs
Description
The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs will be determined.
Time Frame
Baseline (Day 1) and Day 30 postvaccination
Title
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs)
Description
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).
Time Frame
Day 30 postvaccination
Title
Serotype-specific geometric mean fold rise (GMFR) in OPA GMTs
Description
The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA.
Time Frame
Baseline (Day 1) and Day 30 postvaccination
Title
Serotype-specific GMFR in IgG GMCs
Description
The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL.
Time Frame
Baseline (Day 1) and Day 30 postvaccination
Title
Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs (all serotypes)
Description
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs will be determined with MOPA.
Time Frame
Baseline (Day 1) and Day 30 postvaccination
Title
Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs
Description
The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs will be determined using PnECL.
Time Frame
Baseline (Day 1) and Day 30 postvaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 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 inclusion 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 PPSV23, 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 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
Fundacion Estudios Clinicos ( Site 0200)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DEJ
Country
Argentina
Facility Name
Paratus Clinical Research Western Sydney ( Site 1500)
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Northern Beaches Clinical Research ( Site 1502)
City
Brookvale
State/Province
New South Wales
ZIP/Postal Code
2100
Country
Australia
Facility Name
Paratus Clinical Research Brisbane ( Site 1501)
City
Albion
State/Province
Queensland
ZIP/Postal Code
4010
Country
Australia
Facility Name
IPS Centro Científico Asistencial S.A.S ( Site 0407)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Fundacion Valle del Lili- CIC ( Site 0415)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
klinikum rechts der isar der technischen universität münchen ( Site 0904)
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
InfektioResearch ( Site 0903)
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Medizentrum Essen Borbeck ( Site 0902)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Universitaetsklinikum Koeln ( Site 0900)
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Rambam Health Care Campus ( Site 1002)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center-Infectious unit ( Site 1003)
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Sheba Medical Center ( Site 1000)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1001)
City
Sakhnin
ZIP/Postal Code
3081000
Country
Israel
Facility Name
Wonju Severance Christian Hospital ( Site 1808)
City
Wonju
State/Province
Kang-won-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital-Infectious Diseases ( Site 1811)
City
Gwangju-si
State/Province
Kwangju-Kwangyokshi
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital ( Site 1801)
City
Ansan-si
State/Province
Kyonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Bucheon Hospital ( Site 1812)
City
Bucheon
State/Province
Kyonggi-do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Hallym University Dongtan Sacred Heart Hospital ( Site 1813)
City
Hwaseong-si
State/Province
Kyonggi-do
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 1803)
City
Suwon-si
State/Province
Kyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Dong-A University Hospital ( Site 1810)
City
Busan
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 1804)
City
Deagu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Chungnam national university hospital ( Site 1814)
City
Jung-gu
State/Province
Taejon-Kwangyokshi
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 1802)
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 1809)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1806)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital ( Site 1807)
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 1805)
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 1800)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
P3 Research - Palmerston North ( Site 1602)
City
Palmerston North
State/Province
Manawatu-Wanganui
ZIP/Postal Code
4414
Country
New Zealand
Facility Name
P3 Research - Lower Hutt ( Site 1601)
City
Lower Hutt
State/Province
Wellington
ZIP/Postal Code
5010
Country
New Zealand
Facility Name
Optimal Clinical Trials ( Site 1600)
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
EBA CENTELLES ( Site 1100)
City
Centelles
State/Province
Cataluna
ZIP/Postal Code
08500
Country
Spain
Facility Name
Hospital Universitario Getafe ( Site 1111)
City
Getafe
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28905
Country
Spain
Facility Name
Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118)
City
València
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46015
Country
Spain
Facility Name
Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 1101)
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
EAP Sardenya ( Site 1102)
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital La Princesa-Clinical Pharmacology ( Site 1115)
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital-Infectious diseases Division, Department of
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 1901)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 1900)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-Linkou Branch ( Site 1902)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Sancaktepe Şehit Prof.Dr. İlhan Varank Eğitim ve Arastirma Hastanesi ( Site 1305)
City
Sancaktepe
State/Province
Istanbul
ZIP/Postal Code
34785
Country
Turkey
Facility Name
ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Hacettepe Universite Hastaneleri-İnfection ( Site 1300)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Gazi University Health Research and Application Center Gazi Hospital-Enfeksiyon Hastalıkları ( Site
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301)
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405)
City
Shipley
State/Province
Bradford
ZIP/Postal Code
BD18 3SA
Country
United Kingdom
Facility Name
Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 1407)
City
London
State/Province
England
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Royal Free Hospital-Ian Charleson Day Centre RESEARCH ( Site 1402)
City
London
State/Province
England
ZIP/Postal Code
NW32QG
Country
United Kingdom
Facility Name
Layton Medical Centre ( Site 1400)
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
Accellacare - Northamptonshire ( Site 1403)
City
Corby
State/Province
Northamptonshire
ZIP/Postal Code
NN18 9EZ
Country
United Kingdom
Facility Name
Accellacare - Warwickshire ( Site 1404)
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV3 4FJ
Country
United Kingdom

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
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=V116-010&&kw=V116-010
Description
Plain Language Summary

Learn more about this trial

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

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