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Completed

NCT Number: NCT05633992

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

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).

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Corporation Heishinkai OPHAC Hospital ( Site 1008), Osaka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Pneumococcal 21-valent Conjugate Vaccine

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.

Other names: PNEUMOVAX™23

Primary outcomes

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

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

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

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

    Time frame: Day 30 postvaccination

    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).

  5. 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) were determined.

Secondary outcomes

  1. 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 were determined using MOPA.

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

    Time frame: Day 30 postvaccination

    The GMCs for serotype-specific IgG antibodies were determined using pneumococcal electrochemiluminescence (PnECL).

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

    Time frame: Baseline (Day 1) and Day 30 postvaccination

    The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.

  4. 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 was determined using PnECL. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.

  5. 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

    Activity for the serotypes contained in V116 and PPSV23 were determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.

  6. 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

    Activity for the serotypes contained in V116 and PPSV23 were determined using PnECL. The percentage of participants who had ≥4-fold rise in IgG titers were calculated from baseline to postvaccination.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2022
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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