CompletedPhase 2

A Study of IVX-A12 in Adults Participants

United States143 participantsStarted 2024-06-10

Plain-language summary

The primary purpose of this study is to assess the immunogenicity and safety of IVX-A12 in adults 60 years of age and older.

Who can participate

Age range

60 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

. Adults \>=60 years of age at the time of signing informed consent.
. Participants who are medically stable according to the judgment of the Investigator.
. Able to understand and comply with study requirements/procedures based on the assessment of the Investigator.
. Capable of giving signed informed consent.

Exclusion criteria

. Acute (time-limited) or febrile (temperature \>=38.0 °C \[100.4 ºF\]) illness/infection within 3 days of planned dosing.
. History of a clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
. History of hypersensitivity to any component of the study vaccination.
. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis).
. Known or suspected congenital or acquired immunodeficiency.
. Known or suspected autoimmune condition as determined by history and/or physical examination.

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

Model-adjusted Geometric Mean Concentration (GMC) for RSV/A Neutralizing Antibodies (NAb)

Timeframe: At Day 29

Geometric Mean Fold Rise (GMFR) in RSV/A NAb Concentrations

Timeframe: From baseline up to Day 29

Number of Participants With Immediate Unsolicited Adverse Events (AEs)

Timeframe: Within the 30 minutes after vaccination on Day 1

Number of Participants With Injection Site and Systemic Solicited Adverse Reactions (ARs)

Timeframe: Day 1 through Day 8

Number of Participants With Unsolicited Adverse Events (AEs)

Timeframe: Day 1 through Day 29

Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), and Adverse Events of Special Interests (AESIs)

Timeframe: Day 1 through Day 29

Trial details

NCT IDNCT06481579

SponsorIcosavax, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-17

Results submitted2025-07-17

View on ClinicalTrials.gov More Healthy Participants trials

Who can participate

Age range

60 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

. Adults \>=60 years of age at the time of signing informed consent.
. Participants who are medically stable according to the judgment of the Investigator.
. Able to understand and comply with study requirements/procedures based on the assessment of the Investigator.
. Capable of giving signed informed consent.

Exclusion criteria

. Acute (time-limited) or febrile (temperature \>=38.0 °C \[100.4 ºF\]) illness/infection within 3 days of planned dosing.
. History of a clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
. History of hypersensitivity to any component of the study vaccination.
. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis).
. Known or suspected congenital or acquired immunodeficiency.
. Known or suspected autoimmune condition as determined by history and/or physical examination.

What they're measuring

Model-adjusted Geometric Mean Concentration (GMC) for RSV/A Neutralizing Antibodies (NAb)

Timeframe: At Day 29

Geometric Mean Fold Rise (GMFR) in RSV/A NAb Concentrations

Timeframe: From baseline up to Day 29

Number of Participants With Immediate Unsolicited Adverse Events (AEs)

Timeframe: Within the 30 minutes after vaccination on Day 1

Number of Participants With Injection Site and Systemic Solicited Adverse Reactions (ARs)

Timeframe: Day 1 through Day 8

Number of Participants With Unsolicited Adverse Events (AEs)

Timeframe: Day 1 through Day 29

Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), and Adverse Events of Special Interests (AESIs)

Timeframe: Day 1 through Day 29