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Virus Therapy
Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF for Respiratory Syncytial Virus (EVERGREEN Trial)
Phase 3
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
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 from month 12 up to month 24
Awards & highlights
EVERGREEN Trial Summary
This trial will enroll up to 27,500 people to see if the study vaccine prevents RSV-mediated Lower Respiratory Tract Disease (LRTD) better than placebo in adults aged 60 years and above.
Eligible Conditions
- Respiratory Syncytial Virus
- Bronchitis
EVERGREEN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from month 12 up to month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from month 12 up to month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
Secondary outcome measures
Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days Post Vaccination
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year
+10 moreSide effects data
From 2023 Phase 3 trial • 25236 Patients • NCT0490868346%
Vaccination Site Pain(Solicited)
34%
Fatigue(Solicited)
26%
Myalgia(Solicited)
26%
Headache(Solicited)
14%
Nausea(Solicited)
7%
Pyrexia(Solicited)
6%
Blood Pressure Systolic Increased
4%
Respiratory Rate Increased
3%
Vaccination Site Swelling(Solicited)
3%
Vaccination Site Erythema(Solicited)
3%
Cough
2%
Pain
2%
Blood Pressure Diastolic Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Ad26.RSV.preF and RSV preF Protein
Group 2: Placebo
EVERGREEN Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: Respiratory Syncytial Virus (RSV) vaccineExperimental Treatment2 Interventions
All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.
Group II: Group 2: PlaceboPlacebo Group1 Intervention
All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
2021
Completed Phase 3
~25240
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,109,077 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
110,320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Respiratory Syncytial Virus (RSV) vaccine
- Group 2: Group 2: Placebo
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: NCT04908683 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks associated with Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF?
"There is some efficacy data and multiple safety rounds supporting this Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF, so it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Florida
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Velocity Clinical Research, Hallandale Beach
Tekton Research Inc.
Advanced Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I always going there. I want to advance medical knowledge. Have a history of upper respiratory illness due to asthma & allergies. RSV is on the rise. i would like to avoid getting it.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- Advanced Clinical Research: < 48 hours
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