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Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (STRIDE-8)

Primary Purpose

Pneumococcal Infection

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V116
Placebo for PCV15 + PPSV23
PCV15
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 Infection

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Has documented result(s) of ≥1 of the following risk conditions for pneumococcal disease: diabetes mellitus, receiving treatment with ≥1 approved antidiabetic medication, with all Hemoglobin A1c (HbA1c) measurements ≤9% within 6 months before first study vaccination; compensated chronic liver disease; diagnosis of chronic obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild or moderate persistent asthma managed per local guidelines; confirmed diagnosis of chronic heart disease managed per local guidelines; confirmed diagnosis of chronic kidney disease (>3 months duration). Is receiving stable medical management for the listed risk conditions for ≥3 months with no anticipated major change in treatment expected for the duration of the study and with ≤1 hospitalization directly related to the risk condition. Female Is not a participant of childbearing potential (POCBP); or if a POCBP Uses an acceptable contraceptive method or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis); their medical history, menstrual history, and recent sexual activity has been reviewed by the investigator. Exclusion Criteria: Has a history of active hepatitis. Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before first study vaccination (Day 1). Has a history of myocardial infarction, acute coronary syndrome, transient ischemic attack, or ischemic or hemorrhagic stroke within 3 months before first study vaccination (Day 1). Has a history of severe pulmonary hypertension with World Health Organization (WHO) functional class ≥3 or history of Eisenmenger syndrome Has a history of autoimmune related chronic kidney disease, chronic kidney failure, a reversible cause of kidney disease, nephrotic syndrome, or any ineligible Kidney Disease: Improving Global Outcomes (KDIGO)-recommended stage of glomerular filtration rate (GFR) and Albuminuria 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 before first study vaccination (Day 1). Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid. Has a known or suspected impairment of immunological function including, but not limited to, congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or autoimmune disease. Has a coagulation disorder contraindicating intramuscular (IM) vaccination. Had a recent febrile illness or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of any study vaccine. Has a known malignancy that is progressing or has required active treatment <3 years before randomization. Has planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgical procedure during the duration of this study. Has expected survival for <1 year. Has received any prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol. Has 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 at Visit 2 (Day 1). Is currently receiving systemic 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 any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine. Has received any live virus vaccine (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) live virus vaccines) ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of any study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of any study vaccine. Is receiving chronic home oxygen therapy.

Sites / Locations

  • Aventiv Research ( Site 0022)
  • Indago Research & Health Center, Inc ( Site 0002)
  • Triple O Research Institute, P.A ( Site 0011)
  • SKY Integrative Medical Center/SKYCRNG ( Site 0012)
  • Mid Hudson Medical Research ( Site 0008)
  • Holston Medical Group ( Site 0010)
  • EmVenio Research ( Site 0018)
  • Wenatchee Valley Hospital ( Site 0019)
  • Holdsworth House Medical Practice ( Site 0402)
  • Royal Brisbane and Women's Hospital ( Site 0400)
  • G A Research Associates ( Site 0100)
  • Hamilton Medical Research Group ( Site 0107)
  • Milestone Research Inc. ( Site 0106)
  • Manna Research Mirabel ( Site 0105)
  • Clinique de médecine Urbaine du Quartier Latin ( Site 0111)
  • Diex Recherche Trois-Rivieres ( Site 0110)
  • Diex Recherche Victoriavile Inc. ( Site 0102)
  • Hospital Dr. Hernán Henríquez Aravena ( Site 1001)
  • Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010)
  • Universidad San Sebastian - Providencia ( Site 1003)
  • Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008)
  • Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004)
  • Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006)
  • CESFAM Esmeralda ( Site 1009)
  • Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200)
  • Shimonoseki Medical Center ( Site 0201)
  • Hallym University Sacred Heart Hospital ( Site 0303)
  • Korea University Anam Hospital ( Site 0305)
  • Seoul National University Hospital ( Site 0300)
  • Konkuk University Medical Center ( Site 0302)
  • Hallym University Kangdong Sacred Heart Hospital ( Site 0301)
  • Pacific Clinical Research Network - Rotorua ( Site 0500)
  • P3 Research - Tauranga ( Site 0507)
  • CGM Research Trust ( Site 0505)
  • Pacific Clinical Research Network - Forte ( Site 0501)
  • P3 Research - Lower Hutt ( Site 0508)
  • P3 Research - Wellington ( Site 0503)
  • IN VIVO ( Site 0601)
  • Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607)
  • MICS Centrum Medyczne Torun ( Site 0606)
  • Clinmedica Research Sp. z. o. o. ( Site 0603)
  • Centrum Medyczne Medyk ( Site 0602)
  • Centrum Medyczne Pratia Katowice ( Site 0604)
  • Clinical Medical Research ( Site 0605)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

V116

PCV15 + PPSV23

Arm Description

Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo for PCV15 + PPSV23 on Week 8

Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.

Outcomes

Primary Outcome Measures

Participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 post-vaccination
Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 post-vaccination
Participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination
Percentage of participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination
Participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study
Percentage of participants with vaccine-related SAEs from Day 1 through the duration of participation in the study
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) post-vaccination
Serotype-specific OPA GMTs post-vaccination with V116 (30 days post-vaccination [Day 30]) or PCV15 + PPSV23 (30 days post-vaccination with the final dose in the regimen [Week 12])

Secondary Outcome Measures

Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) post-vaccination
Serotype-specific IgG GMCs post-vaccination with V116 (Day 30) and PCV15 + PPSV23 (Week 12)
Serotype-specific geometric mean fold rises (GMFRs) from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses
Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post=vaccination with PCV15 + PPSV2 (Week 12) for OPA responses
Serotype-specific GMFRs from baseline to post-vaccination with V116 and PCV15 + PPSV2 for Immunoglobulin G (IgG) responses
Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV23 (Week 12) for IgG responses
Serotype-specific percentage of participants with a ≥4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses
Serotype-specific percentage of participants with a ≥4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for OPA responses
Serotype-specific percentage of participants with a ≥4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPS for IgG responsesV2
Serotype-specific proportion of participants with a ≥4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for IgG responses

Full Information

First Posted
January 13, 2023
Last Updated
August 23, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05696080
Brief Title
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)
Acronym
STRIDE-8
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 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
February 19, 2024 (Anticipated)
Study Completion Date
February 19, 2024 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination. within each vaccination group separately.

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
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V116
Arm Type
Experimental
Arm Description
Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo for PCV15 + PPSV23 on Week 8
Arm Title
PCV15 + PPSV23
Arm Type
Active Comparator
Arm Description
Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
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
Drug
Intervention Name(s)
Placebo for PCV15 + PPSV23
Intervention Description
Saline in each 0.5 mL sterile solution
Intervention Type
Biological
Intervention Name(s)
PCV15
Other Intervention Name(s)
VAXNEUVANCE™
Intervention Description
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension
Intervention Type
Biological
Intervention Name(s)
PPSV23
Other Intervention Name(s)
PNEUMOVAX™23
Intervention Description
Pneumococcal 23-valent polyvalent 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
Participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 post-vaccination
Description
Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 post-vaccination
Time Frame
Up to Day 5
Title
Participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination
Description
Percentage of participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination
Time Frame
Up to Day 5
Title
Participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study
Description
Percentage of participants with vaccine-related SAEs from Day 1 through the duration of participation in the study
Time Frame
Up to Month 6
Title
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) post-vaccination
Description
Serotype-specific OPA GMTs post-vaccination with V116 (30 days post-vaccination [Day 30]) or PCV15 + PPSV23 (30 days post-vaccination with the final dose in the regimen [Week 12])
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) post-vaccination
Description
Serotype-specific IgG GMCs post-vaccination with V116 (Day 30) and PCV15 + PPSV23 (Week 12)
Time Frame
Up to Week 12
Title
Serotype-specific geometric mean fold rises (GMFRs) from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses
Description
Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post=vaccination with PCV15 + PPSV2 (Week 12) for OPA responses
Time Frame
Baseline and up to Week 12
Title
Serotype-specific GMFRs from baseline to post-vaccination with V116 and PCV15 + PPSV2 for Immunoglobulin G (IgG) responses
Description
Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV23 (Week 12) for IgG responses
Time Frame
Baseline and up to Week 12
Title
Serotype-specific percentage of participants with a ≥4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses
Description
Serotype-specific percentage of participants with a ≥4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for OPA responses
Time Frame
Baseline and up to Week 12
Title
Serotype-specific percentage of participants with a ≥4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPS for IgG responsesV2
Description
Serotype-specific proportion of participants with a ≥4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for IgG responses
Time Frame
Baseline and up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Has documented result(s) of ≥1 of the following risk conditions for pneumococcal disease: diabetes mellitus, receiving treatment with ≥1 approved antidiabetic medication, with all Hemoglobin A1c (HbA1c) measurements ≤9% within 6 months before first study vaccination; compensated chronic liver disease; diagnosis of chronic obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild or moderate persistent asthma managed per local guidelines; confirmed diagnosis of chronic heart disease managed per local guidelines; confirmed diagnosis of chronic kidney disease (>3 months duration). Is receiving stable medical management for the listed risk conditions for ≥3 months with no anticipated major change in treatment expected for the duration of the study and with ≤1 hospitalization directly related to the risk condition. Female Is not a participant of childbearing potential (POCBP); or if a POCBP Uses an acceptable contraceptive method or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis); their medical history, menstrual history, and recent sexual activity has been reviewed by the investigator. Exclusion Criteria: Has a history of active hepatitis. Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before first study vaccination (Day 1). Has a history of myocardial infarction, acute coronary syndrome, transient ischemic attack, or ischemic or hemorrhagic stroke within 3 months before first study vaccination (Day 1). Has a history of severe pulmonary hypertension with World Health Organization (WHO) functional class ≥3 or history of Eisenmenger syndrome Has a history of autoimmune related chronic kidney disease, chronic kidney failure, a reversible cause of kidney disease, nephrotic syndrome, or any ineligible Kidney Disease: Improving Global Outcomes (KDIGO)-recommended stage of glomerular filtration rate (GFR) and Albuminuria 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 before first study vaccination (Day 1). Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid. Has a known or suspected impairment of immunological function including, but not limited to, congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or autoimmune disease. Has a coagulation disorder contraindicating intramuscular (IM) vaccination. Had a recent febrile illness or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of any study vaccine. Has a known malignancy that is progressing or has required active treatment <3 years before randomization. Has planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgical procedure during the duration of this study. Has expected survival for <1 year. Has received any prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol. Has 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 at Visit 2 (Day 1). Is currently receiving systemic 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 any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine. Has received any live virus vaccine (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) live virus vaccines) ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of any study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of any study vaccine. Is receiving chronic home oxygen therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Aventiv Research ( Site 0022)
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Indago Research & Health Center, Inc ( Site 0002)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Triple O Research Institute, P.A ( Site 0011)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
SKY Integrative Medical Center/SKYCRNG ( Site 0012)
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Mid Hudson Medical Research ( Site 0008)
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Holston Medical Group ( Site 0010)
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
EmVenio Research ( Site 0018)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
27713
Country
United States
Facility Name
Wenatchee Valley Hospital ( Site 0019)
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Holdsworth House Medical Practice ( Site 0402)
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital ( Site 0400)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
G A Research Associates ( Site 0100)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Hamilton Medical Research Group ( Site 0107)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Milestone Research Inc. ( Site 0106)
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Manna Research Mirabel ( Site 0105)
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Clinique de médecine Urbaine du Quartier Latin ( Site 0111)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Facility Name
Diex Recherche Trois-Rivieres ( Site 0110)
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 4P3
Country
Canada
Facility Name
Diex Recherche Victoriavile Inc. ( Site 0102)
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Hospital Dr. Hernán Henríquez Aravena ( Site 1001)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010)
City
Talca
State/Province
Maule
ZIP/Postal Code
3460000
Country
Chile
Facility Name
Universidad San Sebastian - Providencia ( Site 1003)
City
Providencia
State/Province
Region M. De Santiago
ZIP/Postal Code
7500000
Country
Chile
Facility Name
Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500692
Country
Chile
Facility Name
Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330034
Country
Chile
Facility Name
Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380420
Country
Chile
Facility Name
CESFAM Esmeralda ( Site 1009)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
9340000
Country
Chile
Facility Name
Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Shimonoseki Medical Center ( Site 0201)
City
Shimonoseki
State/Province
Yamaguchi
ZIP/Postal Code
750-0061
Country
Japan
Facility Name
Hallym University Sacred Heart Hospital ( Site 0303)
City
Anyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital ( Site 0305)
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 0300)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center ( Site 0302)
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Hallym University Kangdong Sacred Heart Hospital ( Site 0301)
City
Seoul
ZIP/Postal Code
05355
Country
Korea, Republic of
Facility Name
Pacific Clinical Research Network - Rotorua ( Site 0500)
City
Rotorua
State/Province
Bay Of Plenty
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
P3 Research - Tauranga ( Site 0507)
City
Tauranga
State/Province
Bay Of Plenty
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
CGM Research Trust ( Site 0505)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Pacific Clinical Research Network - Forte ( Site 0501)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
P3 Research - Lower Hutt ( Site 0508)
City
Lower Hutt
State/Province
Wellington
ZIP/Postal Code
5010
Country
New Zealand
Facility Name
P3 Research - Wellington ( Site 0503)
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
IN VIVO ( Site 0601)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-048
Country
Poland
Facility Name
Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
MICS Centrum Medyczne Torun ( Site 0606)
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Clinmedica Research Sp. z. o. o. ( Site 0603)
City
Skierniewice
State/Province
Lodzkie
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Centrum Medyczne Medyk ( Site 0602)
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice ( Site 0604)
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Clinical Medical Research ( Site 0605)
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-156
Country
Poland

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=V116-008&kw=V116-008
Description
Plain Language Summary

Learn more about this trial

Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)

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