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Cancer Vaccine
IVX-A12 + RSV Vaccine for Older Adults
Phase 2
Waitlist Available
Research Sponsored by Icosavax, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see how well a new drug called IVX-A12 works in adults aged 60 and above, specifically looking at its ability to trigger an immune response and its safety."
Who is the study for?
This trial is for adults aged 60 or older who are medically stable and can understand and follow the study's procedures. They must be able to give informed consent. People with unstable health conditions that could interfere with the trial may not participate.
What is being tested?
The study is testing IVX-A12, a new intervention, in comparison to a licensed RSV vaccine in healthy senior adults. The goal is to evaluate how well IVX-A12 works (its immunogenicity) and its safety profile.
What are the potential side effects?
While specific side effects of IVX-A12 aren't listed, common side effects for vaccines include soreness at injection site, mild fever, fatigue, headache, muscle pain, chills, joint pain or nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Geometric Mean Fold Rise (GMFR) in RSV/A NAb Titers
Geometric Mean Titers (GMT) for RSV/A Neutralizing Antibodies (NAb)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IVX-A12 VaccineExperimental Treatment1 Intervention
Participants will receive a single dose of IVX-A12, 300 micrograms (mcg), intramuscular (IM) injection on Day 1.
Group II: Licensed RSV VaccineActive Control1 Intervention
Participants will receive a single dose of licensed RSV vaccine IM injection on Day 1.
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Who is running the clinical trial?
Icosavax, Inc.Lead Sponsor
2 Previous Clinical Trials
404 Total Patients Enrolled