Your session is about to expire
← Back to Search
RENOIR Trial Summary
This trial will test if RSVpreF is safe and effective in preventing LRTI-RSV in adults.
RENOIR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRENOIR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RENOIR Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I am not able to become pregnant.I am a man who can father children and agree to use effective birth control during and after the study.I have not received blood products or immunoglobulin in the last 60 days.I have never received an RSV vaccine and don't plan to during the study.I can take care of myself and do daily activities on my own.I haven't taken strong immune system medications or had radiation for 60 days.I am willing and able to follow the study's schedule, use a mobile app for symptom tracking, and collect nasal swabs as needed.I am healthy with a stable condition that hasn't needed more treatment or hospitalization in the last 6 weeks.I am willing and able to follow the study's schedule, use a mobile app for symptom tracking, and collect nasal swabs as required.I can take care of myself and live at home or in a place that offers little help.I can sign and follow the study's consent form and rules.I am 60 years old or older.I am not able to become pregnant.I am a man who can father children and agree to use effective birth control during and for 28 days after the study.I do not have a bleeding disorder that makes injections unsafe for me.I do not have any serious chronic conditions that would prevent me from joining the study.I can sign and follow the study's consent form and rules.I am 60 years old or older.
- Group 1: SSB: Vaccination of RSVpreF recipients with Placebo
- Group 2: Efficacy Study: RSVpreF vaccine
- Group 3: Efficacy Study: Placebo dose
- Group 4: SSA: Vaccination of RSVpreF recipients with RSVpreF
- Group 5: SSA: Vaccination of RSVpreF recipients with Placebo
- Group 6: SSB: Vaccination of RSVpreF recipients with RSVpreF
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the goals of this medical research project?
"The primary goal of this clinical trial is to observe the proportion of patients who experience systemic events within 7 days of vaccination. The study will last for an average of 6 months, from Day 15 after vaccination until the end of season 1 visit. Secondary outcomes being observed include the number of first episodes acute respiratory illness (ARI) associated with RSV in the third RSV season, lower respiratory tract infection (LRTI) associated with RSV in the second RSV season, and ARI associated with RSV in the second RSV season. All data regarding these secondary outcomes will be gathered via reverse transcriptase-polymerase chain reaction"
Has the RSVpreF drug been cleared by the FDA?
"RSVpreF's safety is estimated to be a 3. This rating comes from the fact that RSVpreF is in Phase 3 testing, so there is both some efficacy data as well as multiple rounds of safety data."
How many people are participating in this trial to test new medication?
"In order to complete this study, 37630 patients that fit the set inclusion criteria must participate. This can be done at various locations including Benchmark Research in San Antonio and Invictus Clinical Research Group in Pompano Beach, Florida."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Share this study with friends
Copy Link
Messenger