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Virus Vaccine
RSV Vaccine for Respiratory Syncytial Virus (MONET Trial)
Phase 3
Waitlist Available
Research Sponsored by Pfizer
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 throughout the study duration (an average of 7 months)
Awards & highlights
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.
Who is the study for?
This trial is for adults at high risk of severe RSV disease, aged 18-60 with chronic health issues like lung or heart conditions, but not those who are immunocompromised. It's also for adults over 18, including those over 60 with weakened immune systems. Participants must be able to consent and commit to the study schedule.Check my eligibility
What is being tested?
The trial tests a vaccine called RSVpreF against a placebo in one group and gives two doses of the vaccine to another group with weakened immune systems. The goal is to see how well participants' bodies produce antibodies against Respiratory Syncytial Virus after vaccination.See study design
What are the potential side effects?
While specific side effects aren't listed here, common reactions may include pain at the injection site, fatigue, headache, muscle pain, chills, fever, nausea—typical symptoms seen with other vaccines.
MONET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study duration (an average of 7 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study duration (an average of 7 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Substudy A: Primary Immunogenicity - Difference in seroresponse rate of RSV A and RSV B serum neutralizing titers at 1 month after vaccination with RSVpreF between participants in Study C3671023 and in Study C3671013
Substudy A: Primary Immunogenicity - GMT ratio, estimated by the ratio of the geometric mean titers for RSV A and RSV B serum NTs with RSVpreF in Study C3671023 participants to that in Study C3671013 adults ≥60 years of age.
Substudy A: Primary Safety - The proportion of participants reporting adverse events
+11 moreSecondary outcome measures
Substudy A: Secondary Immunogenicity - Geometric mean fold rise of neutralizing titers for RSV A and RSV B
Substudy A: Secondary Immunogenicity - Geometric mean titers of neutralizing titers for RSV A and RSV B
MONET Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Substudy B - RSVpreFExperimental Treatment1 Intervention
Participants will receive 120-µg doses of RSVpreF at Visit 1 and Visit 2 (open label, single arm only)
Group II: Substudy A - RSVpreFExperimental Treatment1 Intervention
Participants will receive a single 120-µg dose of RSVpreF at Visit 1
Group III: Substudy A - PlaceboPlacebo Group1 Intervention
Participants will receive placebo at Visit 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVpreF
2023
Completed Phase 3
~17130
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,910,988 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,156 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Substudy A - RSVpreF
- Group 2: Substudy A - Placebo
- Group 3: Substudy B - RSVpreF
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Respiratory Syncytial Virus Patient Testimony for trial: Trial Name: NCT05842967 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Proactive Clinical Research,LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I believe in the science.
PatientReceived 2+ prior treatments
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