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 range60 Years

SexALL

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.
✕. History of Guillain-Barré syndrome or any other demyelinating condition.
✕. History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.

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 range60 Years

SexALL

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.
✕. History of Guillain-Barré syndrome or any other demyelinating condition.
✕. History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.

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