A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)

• ClinicalTrials.gov Identifier: NCT05526716
• Recruitment Status: Completed
• First Posted: September 2, 2022
• Last Update Posted: June 27, 2023
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: August 31, 2022
• First Posted Date: September 2, 2022
• Last Update Posted Date: June 27, 2023
• Actual Study Start Date: September 23, 2022
• Actual Primary Completion Date: June 21, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 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 ~210 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 after V116 vaccination (Day 30 for concomitant group and Day 60 for sequential group) ]
  Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA).
• GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI) [ Time Frame: Day 30 ]
  Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 31, 2022)

• Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 60 for sequential group) ]
  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 Day 30 post-vaccination for concomitant group. Day 1 (Baseline) and Day 60 post-vaccination for sequential group. ]
  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: Day 1 (Baseline) and Day 30 post-vaccination for concomitant group. Day 1 (Baseline) and Day 60 post-vaccination for sequential group. ]
  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.
• GMFR in Influenza Strain-specific HAI [ Time Frame: Day 1 (Baseline) and Day 30 ]
  Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.
• Percentage of Participants with Influenza Strain-specific HAI Titer ≥1:40 [ Time Frame: Day 30 ]
  Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.
• Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI [ Time Frame: Day 30 ]
  Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.

• 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, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
• Official Title: A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older
• Brief Summary: This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination.
• 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: 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, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
• Biological: QIV
  Single 0.5 mL IM injection
• Biological: Matching Placebo for V116
  Single 0.5 mL of sterile saline IM injection

Study Arms

• Experimental: Concomitant group (V116 + QIV followed by placebo)
  Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30
  Interventions:

  • Biological: V116
  • Biological: QIV
  • Biological: Matching Placebo for V116
• Experimental: Sequential group (placebo + QIV followed by V116)
  Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30
  Interventions:

  • Biological: V116
  • Biological: QIV
  • Biological: Matching Placebo for V116

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 26, 2023): 1080
• Original Estimated Enrollment (submitted: August 31, 2022): 1000
• Actual Study Completion Date: June 21, 2023
• Actual Primary Completion Date: June 21, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent

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
• Has a known hypersensitivity to any component of V116 or any influenza vaccine, 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 <3 years before enrollment
• Is expected to receive any pneumococcal vaccine during the study outside of the protocol
• Received any pneumococcal vaccine <12 months prior to enrollment (including pneumococcal 13-valent conjugate vaccine [PCV13] followed by pneumococcal 23-valent polysaccharide vaccine [PPSV23] and PPSV23 followed by PCV13)
• Had prior administration of PCV15 or PCV20
• Received any influenza vaccine <6 months prior to enrollment or is expected to receive any influenza vaccine during the study outside of 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
• 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 before the Day 30 postvaccination blood draw is complete
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study

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: United States

Administrative Information

• NCT Number: NCT05526716
• Other Study ID Numbers: V116-005
• 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: June 2023