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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
Pivotal Trial

Summary

This trial is testing a new vaccine to see if it is safe and effective in adults who are at high risk of severe RSV illness. The study includes adults with chronic conditions and those with weakened immune systems. The vaccine helps the body make antibodies to fight the virus.

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study duration (an average of 7 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study duration (an average of 7 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more
Secondary study objectives
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

Side effects data

From 2024 Phase 2 trial • 1142 Patients • NCT05886777
57%
Injection site pain (PAIN AT THE INJECTION SITE)
42%
Fatigue (FATIGUE)
21%
Headache (HEADACHE)
13%
Myalgia (NEW OR WORSENED MUSCLE PAIN)
11%
Diarrhoea (DIARRHEA)
10%
Chills (CHILLS)
8%
Arthralgia (NEW OR WORSENED JOINT PAIN)
8%
Injection site erythema (REDNESS)
5%
Injection site swelling (SWELLING)
4%
Pyrexia (FEVER)
2%
Vomiting (VOMITING)
2%
Rash
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 2: [RSVpreF+BNT162b2] + Placebo
Group 3: BNT162b2 + Placebo
Group 4: RSVpreF + Placebo
Group 1: [RSVpreF + BNT162b2] + QIV
Group 5: QIV + Placebo
Group 6: RSVpreF + BNT162b2 + Placebo
Group 7: RSVpreF + BNT162b2 + QIV

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~17240

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Respiratory Syncytial Virus (RSV) include supportive care and, in some cases, antiviral medications. However, vaccines like RSVpreF are being studied for their ability to stimulate the immune system to produce antibodies against RSV. These antibodies can neutralize the virus, preventing it from infecting cells and reducing the severity of the illness. This mechanism is crucial for RSV patients, especially those at high risk of severe disease, as it can potentially prevent complications and reduce the need for hospitalization.
New therapies for acute RSV infections: where are we?

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Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,716,296 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,152 Total Patients Enrolled

Media Library

RSVpreF (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05842967 — Phase 3
Respiratory Syncytial Virus Research Study Groups: Substudy A - RSVpreF, Substudy A - Placebo, Substudy B - RSVpreF
Respiratory Syncytial Virus Clinical Trial 2023: RSVpreF Highlights & Side Effects. Trial Name: NCT05842967 — Phase 3
RSVpreF (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05842967 — Phase 3
Respiratory Syncytial Virus Patient Testimony for trial: Trial Name: NCT05842967 — Phase 3
~343 spots leftby Dec 2025