Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adu… (NCT07284654) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49
United States4,049 participantsStarted 2025-12-01
Plain-language summary
The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.
Who can participate
Age range
18 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:
* Male or female ≥18 years of age (inclusive) at the time of randomization into the study.
* Able and willing to complete the informed consent process.
* Available for clinical follow-up through the last study visit.
* In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator).
* Willing to have blood samples collected and used for research purposes.
* Able to provide proof of identity to the satisfaction of the site personnel completing the enrollment process.
* Female participants of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method.
* Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary).
Exclusion Criteria:
* History of invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age.
* Previous receipt of any licensed or investigational pneumococcal vaccine at any age.
* Receipt of any investigational product within 30 days prior to Day 1, currently participating in another inter…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Serotype-specific OPA geometric mean titers (GMT) in 50 year olds and above
Timeframe: 1 month after vaccination
2
Percentage of subjects reporting solicited local adverse events (AE) (redness, swelling, and pain at injection site)
Timeframe: up to 7 days after vaccination
3
Percentage of subjects reporting solicited systemic AE (fever, headache, fatigue, muscle pain, and joint pain)
Timeframe: up to 7 days after vaccination
4
Percentage of subjects reporting unsolicited AE
Timeframe: up to 31 days after vaccination
5
Percentage of subjects reporting serious adverse events (SAE), new onset of chronic illness (NOCI), and medically attended adverse events (MAAE)
Timeframe: up to 6 Months after vaccination
6
Serotype-specific OPA geometric mean titers (GMT) in 18 to 49 year olds and 50 to 64 year olds