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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05526716
Recruitment Status : Active, not recruiting
First Posted : September 2, 2022
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Pneumococcal Biological: V116 Biological: QIV Biological: Matching Placebo for V116 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : September 23, 2022
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05526716


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05526716    
Other Study ID Numbers: V116-005
First Posted: September 2, 2022    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Pneumococcal
Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Pneumonia, Bacterial