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Completed

NCT Number: NCT05526716

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)

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) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.

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Key information

Conditions

Pneumonia, Pneumococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Pneumococcal Infections Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012), Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Any underlying chronic conditions were assessed to be in stable condition per the investigator's judgment
  • 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

  • History of IPD or other culture-positive pneumococcal disease
  • Known or suspected impairment of immunological function
  • Receipt of systemic corticosteroids or immunosuppressive therapy
  • Received any pneumococcal vaccine <12 months prior to enrollment
  • Prior administration of PCV15 or PCV20
  • Received any influenza vaccine <6 months prior to enrollment

Treatment and study plan

V116

Biological

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

QIV

Biological

Single 0.5 mL IM injection

Matching Placebo for V116

Biological

Single 0.5 mL of sterile saline IM injection

Primary outcomes

  1. Number 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. Solicited injection-site AEs included erythema, pain, and swelling.

  2. Number 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. Solicited systemic AEs include fatigue, headache, myalgia, and pyrexia.

  3. Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)

    Time frame: Up to ~6 months postvaccination with V116

    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 are summarized.

  4. Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses

    Time frame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)

    OPA for the serotypes in V116 were determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs (GMTs) (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated.

  5. GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)

    Time frame: Day 30

    GMTs for the 4 strains contained in QIV vaccine were determined using an HAI assay.

Secondary outcomes

  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 59 for sequential group)

    The GMCs of serotype-specific IgG for the serotypes contained in V116 were determined using a pneumococcal electrochemiluminescence (Pn ECL) assay.

  2. Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA

    Time frame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)

    OPA for the serotypes in V116 were determined using a MOPA. GMFR ratio is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.

  3. GMFR Ratio of Serotype-specific IgG

    Time frame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)

    GMFR ratios for the serotype-specific IgG in V116 were determined using a Pn ECL.

  4. GMFR in Influenza Strain-specific HAI

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

    Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.

  5. Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40

    Time frame: Day 30

    The percentage of participants with seroconversion is presented. Activity for the 4 strains contained in QIV vaccine was determined using an HAI assay.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2022
Registry last updated
Oct 29, 2025

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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