A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concom… (NCT05526716) | Clinical Trial Compass
CompletedPhase 3
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)
United States1,080 participantsStarted 2022-09-23
Plain-language 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) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a pneumococcal vaccine called V116 given at the same time as a flu shot in people 50 and older — since the study is now completed, has the safety data been published, and what did it show about injection-site reactions and other side effects when both vaccines were given together?
2The trial measured something called opsonophagocytic activity to see how well the immune system responded to the pneumococcal strains in V116 — can you explain what those immune response results might mean for how well this vaccine could actually protect against pneumococcal pneumonia?
3Since this was a Phase 3 trial, how does the evidence from this stage compare to what's already known about the pneumococcal vaccines I might currently be eligible for, like Prevnar 20 or Pneumovax 23?
4V116 appears to target specific pneumococcal serotypes — do you know which serotypes it covers, and would those be relevant to my personal risk of pneumococcal disease based on my age and health history?
5Given that this trial is completed and I'm already in the 50-and-older age group it studied, is V116 something that might become available to me soon, or should we focus on currently approved options while I wait to see what happens next with this vaccine?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Solicited Injection-site Adverse Events (AEs)
Timeframe: Up to 5 days post-vaccination
2
Number of Participants With Solicited Systemic AEs
Timeframe: Up to 5 days post-vaccination
3
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
Timeframe: Up to ~6 months postvaccination with V116
4
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses
Timeframe: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
5
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)