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Virus Therapy
RSV Vaccine for Older Adults
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 36
Awards & highlights
Study Summary
This trial will assess the safety and long-term effectiveness of a new RSV vaccine in adults aged 60+. The study will also evaluate the safety and effectiveness of additional doses of the vaccine given at different intervals.
Who is the study for?
Adults aged 60 or older, both from the community and long-term care facilities, can join this trial if they're medically stable. This includes those with controlled chronic conditions like diabetes or heart disease. People with severe allergies to vaccine ingredients, latex hypersensitivity, significant illnesses preventing study completion, recent use of immune-modifying drugs, a history of RSV vaccination or substance abuse cannot participate.Check my eligibility
What is being tested?
The trial is testing an investigational RSV vaccine called RSVPreF3 OA in seniors. It aims to evaluate the safety and immune response up to three years after a single dose. The study will also look at how people respond to additional doses given on different schedules.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site such as pain and swelling, general symptoms like fever or fatigue, allergic responses due to vaccine components, and other possible immune-related effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years or older and live at home or in a long-term care facility.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at month 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6
+5 moreSecondary outcome measures
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13
+55 moreSide effects data
From 2022 Phase 3 trial • 976 Patients • NCT0484157753%
Injection site pain
23%
Fatigue
22%
Headache
22%
Myalgia
17%
Arthralgia
5%
Injection site erythema
4%
Injection site swelling
3%
Pyrexia
2%
Cough
1%
Epistaxis
1%
Death
1%
Injection site bruising
1%
Back pain
1%
Upper respiratory tract infection
1%
Oropharyngeal pain
1%
Nausea
1%
Pain
1%
Neck pain
1%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Co-Ad Group
Control Group
Trial Design
3Treatment groups
Experimental Treatment
Group I: RSV_flexible revaccination GroupExperimental Treatment1 Intervention
Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 24 months post-Dose 1 and at 48 months post-Dose 1, respectively and are followed up until the study end (Month 60).
Group II: RSV_annual GroupExperimental Treatment1 Intervention
Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and are followed up until the study end (Month 60).
Group III: RSV_1dose GroupExperimental Treatment1 Intervention
Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until Month 36. At Month 36, participants in this group will be re-randomized in 2 groups (RSV_1dose_M36 and RSV_1dose_flexible groups), which will be followed up until the study end (Month 60).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVPreF3 OA investigational vaccine
2021
Completed Phase 3
~2780
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,065,752 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe or unstable long-term illness.You have had a strong allergic reaction to any ingredient in the vaccine in the past.You have a strong allergic reaction to latex.I haven't used any experimental drugs or vaccines in the last 30 days and won't use any during the study.I am 60 years or older and live at home or in a long-term care facility.I am bedridden.I have been vaccinated against RSV before.I haven't received immunoglobulins or blood products in the last 90 days.I am not taking or planning to take long-acting immune drugs during the study.I have a condition that affects my thinking or memory.My neurological condition is under control and won't interfere with the study requirements.I haven't taken long-term immune system drugs or high-dose steroids recently.I have a condition or take medication that weakens my immune system.I haven't received vaccines not allowed by the study within 30 days around each dose of the study vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: RSV_1dose Group
- Group 2: RSV_annual Group
- Group 3: RSV_flexible revaccination Group
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: NCT04732871 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please estimate the number of institutions where this research project is taking place?
"There are 18 clinical trial sites for this research project, which are situated in The Villages, Phoenix, Norfolk and other locations. To cut down on travel, it is recommended you select the location closest to you."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
GSK Investigational Site
Why did patients apply to this trial?
Help people out. To receive compensation for volunteering.
PatientReceived 2+ prior treatments
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