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Virus Therapy
MVA-BN-RSV vaccine for Respiratory Syncytial Virus
Phase 3
Waitlist Available
Research Sponsored by Bavarian Nordic
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 over one rsv season (at least 6 months, and up to 12 months post vaccination)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests a new RSV vaccine in adults aged 60 and older. The vaccine helps the immune system recognize and fight the virus, aiming to prevent severe infections.
Eligible Conditions
- Respiratory Syncytial Virus (RSV)
- Respiratory Syncytial Virus Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over one rsv season (at least 6 months, and up to 12 months post vaccination)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over one rsv season (at least 6 months, and up to 12 months post vaccination)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of LRTD
Secondary study objectives
Occurrence of ARD
Occurrence of any grade 3 or higher adverse events
Occurrence of any serious adverse events
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2: Single dose PlaceboExperimental Treatment1 Intervention
Single dose of TBS (intramuscular injection; 0.5mL)
Group II: Group 1: Single dose MVA-BN-RSVExperimental Treatment1 Intervention
Single dose (Week 0): MVA-BN-RSV virus with a titer of at least 3x10E8 Inf.U/0.5mL (intramuscular vaccination)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MVA-BN-RSV vaccine
2022
Completed Phase 3
~21660
Tris Buffered Saline (TBS)
2022
Completed Phase 3
~21660
Find a Location
Who is running the clinical trial?
Bavarian NordicLead Sponsor
62 Previous Clinical Trials
28,732 Total Patients Enrolled
Bernard Hoet, MDStudy DirectorBavarian Nordic GmbH
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not currently suffering from a life-limiting or debilitating disease.You have some long-term medical conditions such as heart disease, lung disease, high blood pressure, diabetes, high cholesterol, or underactive thyroid, but they are not causing major problems and are stable according to your doctor.You are at least 60 years of age.\nYou have been drinking too much alcohol regularly or recently (within the past 6 months).You are willing and able to use an application on a personal device (i.e., smartphone, tablet, etc.) or a provisioned device to record solicited events and record all per protocol required data during the surveillance period.You have a condition that affects your immune system, like chronic inflammatory bowel disorders.You have a history of severe allergic reactions or allergies to any of the ingredients in the vaccine, such as eggs or certain medications.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2: Single dose Placebo
- Group 2: Group 1: Single dose MVA-BN-RSV
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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: NCT05238025 — Phase 3
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