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RSV Vaccine for Respiratory Syncytial Virus (MONET Trial)
MONET Trial Summary
This trial will test the safety and effectiveness of a vaccine (RSVpreF) to help fight against a virus (RSV) that can cause severe illness in adults. Participants will receive shots and have blood samples taken at the study clinic visits.
MONET Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MONET Trial Design
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Who is running the clinical trial?
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- I do not have enough muscle in my upper arm for shots.I have never received an RSV vaccine and don't plan to during the study.My condition has been stable without major treatment changes or hospital visits for worsening symptoms in the last 3 months.I've needed regular doctor visits or medication, or was hospitalized in the last year.I am willing and able to follow the study's schedule and requirements.I haven't received any RSV monoclonal antibodies in the last 6 months.I haven't received blood products or immunoglobulin in the last 60 days.I have a bleeding condition that makes injections unsafe for me.I am between 18 and 59 years old.I am able to understand and sign the consent form.I have a chronic condition that has lasted more than 6 months.I have a chronic condition like asthma, heart disease (not just high blood pressure), kidney, liver, nerve, blood, or metabolic disorders including diabetes.I have advanced lung cancer, am on dialysis, take stable immunomodulators, or had an organ transplant over 3 months ago.My condition has been stable without needing major treatment changes for 6 weeks.I have a long-term health condition like asthma, heart disease (not just high blood pressure), kidney, liver, nerve, blood, or metabolic disorders including diabetes.This is a specific part of the study called Substudy A.
- Group 1: Substudy A - RSVpreF
- Group 2: Substudy A - Placebo
- Group 3: Substudy B - 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
To what extent is the participant size of this medical experiment extended?
"In order to effectively accomplish this trial, the sponsor Pfizer must recruit 725 participants that align with their inclusion criteria. These enrollees can be found at Clinical Research Associates in Birmingham, Arizona and Medical Affiliated Research Center in Huntsville, California."
Are there multiple locations in Canada conducting this clinical research experiment?
"31 medical centres are currently enrolling for this study, including in Birmingham, Huntsville and Phoenix. To reduce travel requirements on participants, it is crucial to select the nearest clinic when signing up."
Has Substudy A met the regulatory requirements of the FDA?
"Our team has accorded Substudy A a score of 3 due to the existence of clinical evidence indicating its efficacy and numerous rounds verifying its safety, as it is currently in Phase 3."
Is the opportunity for participation in this trial still available to those interested?
"Affirmative. Clinicaltrials.gov confirms that this investigation, which was firstly shared with the public on May 11th 2023, is actively seeking participants. Around 725 volunteers across 31 various medical centres are needed for the trial's success."
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