A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

• ClinicalTrials.gov Identifier: NCT05464420
• Recruitment Status: Completed
• First Posted: July 19, 2022
• Last Update Posted: March 4, 2024
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: July 12, 2022
• First Posted Date: July 19, 2022
• Last Update Posted Date: March 4, 2024
• Actual Study Start Date: August 12, 2022
• Actual Primary Completion Date: May 25, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 12, 2022)

• Percentage of participants with solicited injection-site adverse events (AEs) [ Time Frame: Up to ~5 days ]
  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 include pain/tenderness, redness/erythema, and swelling.
• Percentage of participants with solicited systemic AEs [ Time Frame: Up to ~5 days ]
  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 include headache, muscle aches/myalgia, and tiredness/fatigue.
• Percentage of participants with vaccine-related serious adverse events (SAEs) [ Time Frame: Up to ~6 months ]
  An 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 titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) for all serotypes in V116 following vaccination with 1 of 3 different lots of V116 [ Time Frame: Day 30 ]
  Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using multiplex opsonophagocytic assay (MOPA).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 12, 2022)

• GMTs of serotype-specific OPA for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™ [ Time Frame: Day 30 ]
  Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using MOPA.
• Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) for all serotypes in V116 following vaccination with separate V116 lots [ Time Frame: Day 30 ]
  Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using pneumococcal electrochemiluminescence (PnECL).
• GMCs of serotype-specific IgG for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™ [ Time Frame: Day 30 ]
  Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using PnECL.
• Geometric mean fold rise (GMFR) in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots [ Time Frame: Baseline (Day 1) and Day 30 ]
  Serotype-specific OPA GMFR for all serotypes in V116 following vaccination will be determined using MOPA.
• Percentage of participants with ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots [ Time Frame: Baseline (Day 1) and Day 30 ]
  Percentage of participants with a ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination will be reported.
• GMFR in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots [ Time Frame: Baseline (Day 1) and Day 30 ]
  Serotype-specific IgG GMFR for all serotypes in V116 following vaccination will be determined using PnECL.
• Percentage of participants with ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots [ Time Frame: Baseline (Day 1) and Day 30 ]
  Percentage of participants with a ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination will be reported.
• GMTs of serotype-specific OPA for cross-reactive serotypes following vaccination with separate V116 Lots [ Time Frame: Day 30 ]
  Serotype-specific OPA GMTs for cross-reactive serotypes following vaccination will be determined using MOPA.

• 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: A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
• Official Title: A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age

Brief Summary

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.

The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.

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

Intervention

• Biological: V116
  Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
  Other Name: Pneumococcal 21-valent Conjugate Vaccine
• Biological: PPSV23
  Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following 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: V116 Lot 1
  Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.
  Intervention: Biological: V116
• Experimental: V116 Lot 2
  Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1.
  Intervention: Biological: V116
• Experimental: V116 Lot 3
  Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1.
  Intervention: Biological: V116
• Active Comparator: PPSV23
  Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.
  Intervention: Biological: PPSV23

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 1, 2024): 2162
• Original Estimated Enrollment (submitted: July 12, 2022): 2040
• Actual Study Completion Date: May 25, 2023
• Actual Primary Completion Date: May 25, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Inclusion Criteria:

• Has underlying chronic conditions but assessed to be stable as per investigator
• Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator

Exclusion Criteria:

• Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
• Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
• Has a coagulation disorder contraindicating intramuscular vaccination
• Has a recent illness with fever
• Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
• Is expected to receive any pneumococcal vaccine during the study outside of the protocol
• Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥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
• 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 study vaccine
• Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
• Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Canada, Denmark, Finland, Israel, Poland, Spain, United States

Administrative Information

• NCT Number: NCT05464420
• Other Study ID Numbers: V116-004; 2022-000265-41 ( 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: February 2024