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

NCT05633992 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: V116-009jRCT2031220551
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 8

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).

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (5)

• 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. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.

  Up to 5 days postvaccination

• 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. The solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue.

  Up to 5 days postvaccination

• 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 another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized.

  Up to 30 days postvaccination

• Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)

  The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA).

  Day 30 postvaccination

• 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) were determined.

  Baseline (Day 1) and Day 30 postvaccination

Secondary Outcomes (6)

• Serotype-specific OPA GMTs (Unique Serotypes)

  Day 30 postvaccination

• Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)

  Day 30 postvaccination

• Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT

  Baseline (Day 1) and Day 30 postvaccination

• Serotype-specific GMFR in IgG GMCs

  Baseline (Day 1) and Day 30 postvaccination

• Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)

  Baseline (Day 1) and Day 30 postvaccination

Study Arms (2)

V116

EXPERIMENTAL

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

Biological: V116

PPSV23

ACTIVE COMPARATOR

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

Biological: PPSV23

Interventions

V116 BIOLOGICAL

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, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.

Also known as: Pneumococcal 21-valent Conjugate Vaccine

V116

PPSV23 BIOLOGICAL

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.

Also known as: PNEUMOVAX™23

PPSV23

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Is Japanese

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (8)

Medical Corporation Heishinkai OPHAC Hospital ( Site 1008)

Osaka, Osaka, 532-0003, Japan

Location

Medical Corporation Heishinkai OCROM Clinic ( Site 1003)

Suita-shi, Osaka, 565-0853, Japan

Location

P-One Clinic ( Site 1001)

Hachiōji, Tokyo, 192-0071, Japan

Location

Heishinkai Medical Group ToCROM Clinic ( Site 1004)

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1006)

Shinjuku-ku, Tokyo, 160-0017, Japan

Location

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1005)

Toshima City, Tokyo, 171-0014, Japan

Location

PS Clinic ( Site 1002)

Fukuoka, 812-0025, Japan

Location

Nishikumamoto Hospital ( Site 1007)

Kumamoto, 861-4157, Japan

Location

Related Publications (1)

• Kishino H, Inoue S, Matsuoka O, Yagi M, Igarashi R, Oshima N, Sawata M, Platt HL. A phase 3 randomized trial (STRIDE-9) to evaluate the safety, tolerability, and immunogenicity of V116, a population-specific pneumococcal conjugate vaccine, in pneumococcal vaccine-naive Japanese adults >/=65 years of age. Vaccine. 2025 Aug 30;62:127456. doi: 10.1016/j.vaccine.2025.127456. Epub 2025 Aug 5.

  PMID: 40763490 DERIVED

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: January 10, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: October 2, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (8)