BridgeMD
A study to evaluate the efficacy, immunogenicity, and safety of an RSV and hMPV VLP vaccine compared with placebo in participants aged 60 years of age and older
EU CTIS ID: 2024-513740-28-00
What this study is testing
To demonstrate the efficacy of a single IM vaccination with IVX-A12 in preventing confirmed RSV LRTD and hMPV LRTD (any severity) in adults ≥ 60 years old during the first season compared to placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant ≥ 60 years of age at the time of signing the informed consent.
- Participants who are medically stable in the opinion of the Investigator at the time of study intervention. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension, or cardiac disease, are allowed to participate in this study if considered by the Investigator as medically stable.
- Able to understand and comply with study requirements/procedures including attending all scheduled study visits (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined) based on the assessment of the Investigator.
You likely can't join if
- Receipt of any licensed or investigational RSV and/or hMPV vaccine within the past 6 months prior to administration of study intervention, or planned receipt during the study.
- History of a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder) contraindicating IM injections or venipuncture based on Investigator judgement.
- History of hypersensitivity to any component of the study intervention.
- History of severe AR associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- India
- Japan
- Philippines
- New Zealand
- Australia
- Colombia
- Korea, Republic of
- Argentina
- Thailand
- Puerto Rico
- Saudi Arabia
- Brazil
- South Africa
- Canada
- United Arab Emirates
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; India; Japan; Philippines; New Zealand; Australia and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.