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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
A male or female participant 50-59 YOA at the time of the study intervention administration.
- Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 4 days after study intervention administered at day 1
Awards & highlights
Study Summary
This trial tests if a vaccine for RSV is safe and effective in adults 50-59, including those at higher risk, compared to those over 60.
Who is the study for?
Adults aged 50-59, including those at higher risk of severe respiratory illness, and healthy or stable older adults over 60 can join. Participants must be able to follow the study plan and women must use contraception if of childbearing potential. Exclusions include immune system issues, hypersensitivity to vaccine components, unstable chronic illnesses, cognitive impairments preventing study completion, recent or planned use of other investigational products.Check my eligibility
What is being tested?
The trial is testing an RSV vaccine called RSVPreF3 OA in adults aged 50-59 against those over 60 to see if it's just as good at creating an immune response. It also looks at safety. Some people will get the real vaccine while others will get a placebo (a shot with no active ingredients).See study design
What are the potential side effects?
Possible side effects from the RSVPreF3 OA vaccine may include typical reactions like soreness where you got the shot, tiredness, headache or mild fever. Since it's under investigation, there might be unknown risks which are being monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 59 years old.
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I have a long-term lung condition that limits my activities or requires ongoing medication.
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I have a long-term heart condition.
Select...
I have diabetes, either type 1 or type 2.
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I have chronic kidney disease.
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I am 60 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 4 days after study intervention administered on day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 4 days after study intervention administered on day 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
RSV-A neutralization titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA
RSV-A neutralization titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA
RSV-A neutralization titers expressed as group geometric mean titer (GMT) ratio in healthy participants compared to OA
+5 moreSecondary outcome measures
T-Lymphocyte
Frequency of RSVPreF3-specific cluster of differentiation (CD)4+ T cells expressing at least 2 activation markers
Percentage of participants reporting SAEs related to study intervention administration
+9 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
5Treatment groups
Experimental Treatment
Placebo Group
Group I: OA-RSV GroupExperimental Treatment1 Intervention
Older adults (OA) ≥60 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.
Group II: Adults HA-RSV GroupExperimental Treatment1 Intervention
Healthy adults (HA) 50-59 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.
Group III: Adults AIR-RSV GroupExperimental Treatment1 Intervention
Adults at increased risk (AIR) 50-59 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.
Group IV: Adults HA-Placebo GroupPlacebo Group1 Intervention
HA 50-59 YOA, who receive 1 dose of placebo at Day 1.
Group V: Adults AIR-Placebo GroupPlacebo Group1 Intervention
Adults AIR 50-59 YOA, who receive 1 dose of placebo at Day 1.
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
4,750 Previous Clinical Trials
8,065,876 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction or are very sensitive to any part of the treatment being used in the study.You are allergic to latex.I have a long-term lung condition that limits my activities or requires ongoing medication.I have not received immunoglobulins or blood products recently.I am taking less than 20 mg/day of prednisone or its equivalent, but I may use inhaled or topical steroids.I haven't taken any long-acting immune drugs like immunotherapy in the last 6 months.I am bedridden.I am a woman who can have children and may join the study.I am between 50 and 59 years old.I have a stable medical condition with no treatment changes in the last 3 months.My chronic conditions like diabetes or heart disease have been stable for the last 3 months.My neurological condition is under control and won't interfere with study requirements.I am a woman who cannot become pregnant due to surgery or being post-menopausal.I live independently or in a place where I mostly take care of myself.I haven't received vaccines not allowed by the study within 30 days around my treatment, except for flu and COVID-19 vaccines.I have a condition or take medication that weakens my immune system.I have chronic kidney disease.I have a long-term heart condition.I have a stable chronic condition like high blood pressure, but it's well-managed.I am 60 years old or older.You have other health conditions that put you at a higher risk of developing respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD).I have been vaccinated against RSV before.I do not have dementia or any condition that severely affects my thinking.I haven't taken immune-modifying drugs for more than 14 days in a row.I am a woman not planning to use birth control or planning to become pregnant.I have diabetes, either type 1 or type 2.I have a long-term liver condition.
Research Study Groups:
This trial has the following groups:- Group 1: Adults HA-Placebo Group
- Group 2: Adults AIR-RSV Group
- Group 3: Adults AIR-Placebo Group
- Group 4: OA-RSV Group
- Group 5: Adults HA-RSV 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any Canadian healthcare facilities that have implemented this clinical trial?
"Currently, 8 locations are enrolling participants in this trial. These include cities such as Victoria, New Westminster and London. If you consider joining the study, it is recommended that you choose the closest site to avoid unnecessary travel expenses."
Answered by AI
Has the Adults HA-RSV Group received federal authorization?
"The safety of the Adults HA-RSV Group is rated 3 due to existing clinical evidence displaying efficacy and multiple studies supporting its security."
Answered by AI
Are individuals being enrolled into this research project currently?
"Clinicaltrials.gov reveals that this research endeavour is still looking for volunteers, with the initial posting date being October 28th 2022 and recent update occurring on November 21st 2022."
Answered by AI
What is the upper limit of participants taking part in this research?
"Yes, the information available on clinicaltrials.gov states that this trial is presently recruiting participants. The initial posting was dated October 28th 2022 and now stands at November 21st as of its last update. This medical research requires 1520 patients to be recruited from 8 different sites."
Answered by AI
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