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Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 3
Locations
Japan
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

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Is Japanese For females, is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) or is a POCBP and uses acceptable contraception/abstinence; has a negative highly sensitive pregnancy test (urine or serum) within 24 (urine) or 72 (serum) hours before the first dose of study intervention; 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

  • Medical Corporation Heishinkai OPHAC Hospital ( Site 1008)
  • Medical Corporation Heishinkai OCROM Clinic ( Site 1003)
  • P-One Clinic ( Site 1001)
  • Heishinkai Medical Group ToCROM Clinic ( Site 1004)
  • Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1006)
  • Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1005)
  • PS Clinic ( Site 1002)
  • Nishikumamoto Hospital ( Site 1007)

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 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 consist 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 AEs (SAEs)
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) [common serotypes]
The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the cross-reactive serotype 15B in V116, and the unique serotype 15C 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 8 unique serotypes contained in V116 (except for 15C) will be determined.

Secondary Outcome Measures

Serotype-specific OPA GMTs (unique serotypes)
The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 will be determined using MOPA.
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs)
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (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 (all serotypes)
The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs will be determined with 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.

Full Information

First Posted
November 21, 2022
Last Updated
May 30, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05633992
Brief Title
Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)
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 Japanese Adults 65 Years of Age or Older
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
May 24, 2023 (Actual)
Study Completion Date
May 24, 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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

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 Japanese adults 65 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 the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Actual)

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 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 consist 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 AEs (SAEs)
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 30 days postvaccination
Title
Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) [common serotypes]
Description
The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the cross-reactive serotype 15B in V116, and the unique serotype 15C 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 8 unique serotypes contained in V116 (except for 15C) will be determined.
Time Frame
Baseline (Day 1) and Day 30 postvaccination
Secondary Outcome Measure Information:
Title
Serotype-specific OPA GMTs (unique serotypes)
Description
The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 will be determined using MOPA.
Time Frame
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
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 (all serotypes)
Description
The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs will be determined with PnECL.
Time Frame
Baseline (Day 1) and 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Is Japanese For females, is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) or is a POCBP and uses acceptable contraception/abstinence; has a negative highly sensitive pregnancy test (urine or serum) within 24 (urine) or 72 (serum) hours before the first dose of study intervention; 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
Medical Corporation Heishinkai OPHAC Hospital ( Site 1008)
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Facility Name
Medical Corporation Heishinkai OCROM Clinic ( Site 1003)
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
P-One Clinic ( Site 1001)
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0071
Country
Japan
Facility Name
Heishinkai Medical Group ToCROM Clinic ( Site 1004)
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1006)
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Facility Name
Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1005)
City
Toshima
State/Province
Tokyo
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
PS Clinic ( Site 1002)
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
Nishikumamoto Hospital ( Site 1007)
City
Kumamoto
ZIP/Postal Code
861-4157
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)

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