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

• ClinicalTrials.gov Identifier: NCT05633992
• Recruitment Status: Completed
• First Posted: December 1, 2022
• Last Update Posted: May 31, 2023
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: November 21, 2022
• First Posted Date: December 1, 2022
• Last Update Posted Date: May 31, 2023
• Actual Study Start Date: January 10, 2023
• Actual Primary Completion Date: May 24, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2022)

• Percentage of participants with solicited injection-site adverse events (AEs) [ Time Frame: Up to 5 days postvaccination ]
  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 [ Time Frame: Up to 5 days postvaccination ]
  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) [ Time Frame: Up to 30 days postvaccination ]
  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] [ Time Frame: Day 30 postvaccination ]
  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) [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 21, 2022)

• Serotype-specific OPA GMTs (unique serotypes) [ Time Frame: Day 30 postvaccination ]
  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) [ Time Frame: Day 30 postvaccination ]
  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) [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
  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) [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
  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 [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
  The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA.
• Serotype-specific GMFR in IgG GMCs [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
  The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Pneumococcal Disease

Intervention

• Biological: V116
  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.
  Other Name: Pneumococcal 21-valent Conjugate Vaccine
• Biological: PPSV23
  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.
  Other Name: PNEUMOVAX™23

Study Arms

• Experimental: V116 Treatment
  Participants receive a single intramuscular (IM) injection of V116 on Day 1.
  Intervention: Biological: V116
• Active Comparator: PPSV23 Treatment
  Participants receive a single IM injection of PPSV23 on Day 1.
  Intervention: Biological: PPSV23

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 30, 2023): 450
• Original Estimated Enrollment (submitted: November 21, 2022): 440
• Actual Study Completion Date: May 24, 2023
• Actual Primary Completion Date: May 24, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT05633992
• Other Study ID Numbers: V116-009; jRCT2031220551 ( Registry Identifier: jRCT )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

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

• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: May 2023