A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

• ClinicalTrials.gov Identifier: NCT05420961
• Recruitment Status: Completed
• First Posted: June 16, 2022
• Results First Posted: May 1, 2024
• Last Update Posted: May 7, 2024
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: June 13, 2022
• First Posted Date: June 16, 2022
• Results First Submitted Date: April 4, 2024
• Results First Posted Date: May 1, 2024
• Last Update Posted Date: May 7, 2024
• Actual Study Start Date: July 12, 2022
• Actual Primary Completion Date: May 16, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2024)

• Percentage of Participants With Solicited Injection-site Adverse Events (AEs) [ Time Frame: Up to 5 days post-vaccination ]
  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
• Percentage of Participants With Solicited Systemic AEs [ Time Frame: Up to 5 days post-vaccination ]
  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
• Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) [ Time Frame: Up to ~180 days ]
  A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, 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. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.
• Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: 30 Days post-vaccination ]
  OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.

Original Primary Outcome Measures (submitted: June 13, 2022)

• Percentage of Participants with Solicited Injection-site Adverse Events (AEs) [ Time Frame: Up to 5 days post-vaccination ]
  An adverse event (AE) is any untoward medical occurrence in a patient or 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 include tenderness/injection-site pain, injection-site redness/injection-site erythema, and injection-site swelling/injection-site swelling.
• Percentage of Participants with Solicited Systemic AEs [ Time Frame: Up to 5 days post-vaccination ]
  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs include muscle aches all over body/myalgia, headache, and tiredness/fatigue.
• Percentage of Participants with Vaccine-related Serious Adverse Events (SAEs) [ Time Frame: Up to ~180 days ]
  A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, 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 will be summarized.
• Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses [ Time Frame: 30 Days post-vaccination ]
  Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA).

Current Secondary Outcome Measures (submitted: April 4, 2024)

• Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: 30 Days post-vaccination ]
  The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.
• Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: Day 1 (Baseline) and 30 days post-vaccination ]
  Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
• Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses [ Time Frame: Day 1 (Baseline) and 30 days post-vaccination ]
  Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.
• Geometric Mean Fold Rise of Serotype-specific IgG [ Time Frame: Day 1 (Baseline) and 30 days post-vaccination ]
  Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
• Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response [ Time Frame: Day 1 (Baseline) and 30 days post-vaccination ]
  Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.

Original Secondary Outcome Measures (submitted: June 13, 2022)

• Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: 30 Days post-vaccination ]
  The GMC of serotype-specific IgG for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an pneumococcal electrochemiluminescence (Pn ECL) assay.
• Geometric Mean Fold Rise (GMFR) of Serotype-specific OPA [ Time Frame: Day 1 (Baseline) and 30 days post-vaccination ]
  Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
• Geometric Mean Fold Rise (GMFR) of Serotype-specific IgG [ Time Frame: Baseline (Day 1) and 30 days post-vaccination ]
  Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an Pn ECL assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
• Official Title: A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older
• Brief Summary: This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
• Detailed Description: Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Cohorts 1 and 2: participants, investigator, sponsor Cohort 3: no blinding

Primary Purpose: Prevention

• Condition: Pneumonia, Pneumococcal

Intervention

• Biological: V116
  Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
  Other Name: Pneumococcal 21-valent Conjugate Vaccine
• Biological: PCV15
  Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension
  Other Name: VAXNEUVANCE™
• Biological: PPSV23
  Pneumococcal 23-valent vaccine with 25 μg of each of the 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
  Other Name: PNEUMOVAX™23

Study Arms

• Experimental: Cohort 1: V116
  Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
  Intervention: Biological: V116
• Active Comparator: Cohort 1: PCV15
  Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
  Intervention: Biological: PCV15
• Experimental: Cohort 2: V116
  Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
  Intervention: Biological: V116
• Active Comparator: Cohort 2: PPSV23
  Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
  Intervention: Biological: PPSV23
• Experimental: Cohort 3: V116
  Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
  Intervention: Biological: V116

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 22, 2023): 717
• Original Estimated Enrollment (submitted: June 13, 2022): 700
• Actual Study Completion Date: May 16, 2023
• Actual Primary Completion Date: May 16, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).

Exclusion Criteria:

• Has a history of invasive pneumococcal disease (IPD).
• Has a known hypersensitivity to any component of V116, PCV15, PCV20, 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 intramuscular vaccination.
• Has a known malignancy that is progressing or has required active treatment.
• Has received PPSV23 followed by either PCV15 or PCV20.
• Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
• 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.
• Has received any non-live vaccine ≤14 days before receipt of 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 ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine.
• Has 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 post-vaccination blood draw is complete.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, France, Israel, Italy, Japan, Korea, Republic of, Spain, Taiwan, United States

Administrative Information

• NCT Number: NCT05420961
• Other Study ID Numbers: V116-006; jRCT2071220025 ( Registry Identifier: jRCT ); 2021-006679-41 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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: April 2024