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Cancer Vaccine
RSV Vaccine for Adults 60+ (RSV OA=ADJ=012 Trial)
Phase 3
Recruiting
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 who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV_1dose group)
Be older than 18 years old
Must not have
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy based on medical history and physical examination
Recurrent or un-controlled neurological disorders or seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to determine the best time for a follow-up vaccination after the initial dose of the RSVPreF3 OA vaccine. It also aims to assess how long the immune response lasts and the
Who is the study for?
This trial is for adults aged 60 and above who previously took part in the RSV OA=ADJ-006 study. It's designed to assess the timing for a second vaccine dose, long-term safety, and immune response over approximately five RSV seasons.
What is being tested?
The study tests the RSVPreF3 OA vaccine's effectiveness in preventing Respiratory Syncytial Virus (RSV). Participants will either receive a follow-up dose or their first actual vaccine if they initially received a placebo.
What are the potential side effects?
While specific side effects are not listed here, vaccines like this one may cause reactions at the injection site, mild fever, fatigue, headache, muscle pain, and joint pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was in the RSV OA=ADJ-006 study and received either a placebo or one dose of the RSVPreF3 OA vaccine.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition or take medication that weakens my immune system.
Select...
I have recurring or uncontrolled seizures or neurological disorders.
Select...
I am bedridden.
Select...
I do not have any serious or unstable chronic illnesses.
Select...
I had a severe reaction to a vaccine in a previous study that may have been caused by the vaccine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side 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%
COVID-19
2%
Nasopharyngitis
1%
Upper respiratory tract infection
1%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Co-Ad Group
Control Group
Awards & 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
4Treatment groups
Experimental Treatment
Active Control
Group I: RSV_PreS5Experimental Treatment1 Intervention
Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 5.
Group II: RSV_PreS4Experimental Treatment1 Intervention
Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 4.
Group III: CrossoverExperimental Treatment1 Intervention
Participants in this group will receive a single dose of RSVPreF3 OA vaccine.
Group IV: RSV_1DoseActive Control1 Intervention
Participants in this group will not receive any additional dose of RSV PreF3 OA vaccine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVPreF3 OA vaccine
2022
Completed Phase 3
~1050
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,372,570 Total Patients Enrolled