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Virus Therapy
RSV Vaccine for Respiratory Syncytial Virus
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the ari visit (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in nh and 2.5-3 years in sh)
Awards & highlights
Study Summary
This trial will study if an investigational RSV vaccine can prevent Lower Respiratory Tract Disease (LRTD) in adults aged 60+. The study will be done in two parts, during the Northern Hemisphere (NH) and Southern Hemisphere (SH) RSV seasons.
Who is the study for?
Adults aged 60 or older, both community-dwelling and in long-term care facilities, who are medically stable with chronic conditions like diabetes or hypertension. Participants must be able to follow the study's procedures, possibly with caregiver assistance if needed. Excludes those with immune deficiencies, serious illnesses that could interfere with the trial, recent use of other investigational products, previous RSV vaccination, substance abuse issues, bedridden individuals or those planning to move during the study.Check my eligibility
What is being tested?
The trial is testing GSK's RSVPreF3 OA vaccine for preventing lower respiratory tract disease caused by RSV in adults over 60 years old. It will assess whether a single dose and annual revaccination are effective and safe while also checking for an immune response.See study design
What are the potential side effects?
While specific side effects aren't listed here, common reactions to vaccines may include soreness at injection site, fatigue, headache, muscle pain; less commonly fever or allergic reactions might occur. The safety profile will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the ari visit (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in nh and 2.5-3 years in sh)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the ari visit (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in nh and 2.5-3 years in sh)
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 Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
Secondary outcome measures
Duration of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes
EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
+34 moreSide effects data
From 2023 Phase 3 trial • 1045 Patients • NCT0556879770%
Injection site pain
45%
Fatigue
38%
Myalgia
32%
Headache
25%
Arthralgia
16%
Injection site erythema
13%
Injection site swelling
3%
Pyrexia
2%
Nasopharyngitis
2%
COVID-19
1%
Bronchitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Co-Ad Group
Control Group
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RSVPreF3 GroupExperimental Treatment2 Interventions
Participants in this group received a single dose of the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants were re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine before Season 2; participants in the other receiving a dose of placebo before Season 2.
Group II: Placebo GroupPlacebo Group1 Intervention
Participants in this group received 1 dose of placebo at Day 1 and received an additional dose of placebo before Season 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
RSVPreF3 OA vaccine
2022
Completed Phase 3
~1050
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,040,804 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 60 years or older and live at home or in a long-term care facility.I haven't received vaccines not allowed by the study within 30 days around each dose of the study vaccine.I can have help with my diary or questionnaire if I'm unable to do it myself.I have a condition that affects my thinking or memory.I have a condition or take medication that weakens my immune system.I haven't taken long-term immune system drugs or high-dose steroids recently.My neurological condition is under control and won't interfere with the study requirements.I haven't used any experimental treatments or devices 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 not taking or planning to take long-acting immune drugs during the study.You have a serious or unstable long-term illness.Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.I have been vaccinated against RSV before.I haven't received immunoglobulins or blood products in the last 90 days.I am bedridden.You have had a bad reaction or allergic response to any part of the vaccine in the past.You are allergic to latex.
Research Study Groups:
This trial has the following groups:- Group 1: RSVPreF3 Group
- Group 2: Placebo Group
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: NCT04886596 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does RSVPreF3 OA Lot 4 compare in safety to other similar treatments?
"RSVPreF3 OA Lot 4 is a Phase 3 trial drug, meaning that it has undergone some efficacy testing and multiple rounds of safety testing. We believe that it is safe to use and rate its safety at a 3."
Answered by AI
Are research subjects still being sought for this experiment?
"No, this specific trial is not looking for more participants at the moment. However, it is worth noting that this clinical trial was originally posted on 5/25/2021 and was most recently edited on 6/28/2022. Additionally, there are 32 other trials that are currently recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
Florida
New York
What site did they apply to?
GSK Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I understand the importance of these kinds of trials for public health.
PatientReceived no prior treatments
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