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Virus Therapy
RSV + Shingles Vaccines for Older Adults (RSV-OA=ADJ-020 Trial)
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 pre-vaccination and at 1-month after the rsvpref3 oa investigational vaccine dose (at day 1 and day 31 for the co-administration group and at day 31 and day 61 for the control group)
Awards & highlights
RSV-OA=ADJ-020 Trial Summary
This trial tests a possible vaccine combo in older adults to see if it can create an immune response and how safe it is.
Who is the study for?
This trial is for healthy adults aged 50 or older who are stable and can care for themselves. They must not be planning pregnancy, have no autoimmune disorders, severe illnesses, or conditions that would interfere with the study. Participants should not have had certain herpes zoster vaccines recently and must avoid other vaccines close to the trial period.Check my eligibility
What is being tested?
The study tests an investigational RSV vaccine (RSVPreF3 OA) given alongside a shingles vaccine (HZ/su) in older adults. It aims to see if the combination is safe and how well it triggers an immune response against these viruses.See study design
What are the potential side effects?
While specific side effects aren't listed here, common reactions to vaccines include soreness at injection site, fatigue, headache, muscle pain, feverish feelings. Severe allergic reactions are rare but possible.
RSV-OA=ADJ-020 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1-month after the second dose of hz/su vaccine (at day 91)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1-month after the second dose of hz/su vaccine (at day 91)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-gE antibody concentrations expressed as group geometric mean concentration (GMC) ratio
Concentration of RSV-A neutralizing titers expressed as group geometric mean titer (GMT) ratio
Concentration of RSV-B neutralizing titers expressed as group GMT ratio
Secondary outcome measures
Anti-gE antibody concentrations expressed as GMC
Anti-gE antibody concentrations expressed as mean geometric increase (MGI)
Anti-gE antibody concentrations expressed as seropositivity rate
+10 moreRSV-OA=ADJ-020 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RSV+ HZ/su Co-administration GroupExperimental Treatment2 Interventions
Participants will be administered first dose of HZ/su vaccine and the RSVPreF3 OA investigational vaccine together on Day 1. A second dose of the HZ/su vaccine will be administered at Day 61.
Group II: RSV+HZ/su Control GroupActive Control2 Interventions
Participants will be administered first dose HZ/su vaccine on Day 1, followed by the RSVPreF3 OA investigational vaccine on Day 31, and then second dose of HZ/su vaccine on Day 61.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVPreF3 OA investigational vaccine
2021
Completed Phase 3
~2780
HZ/su vaccine
2014
Completed Phase 1
~160
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,286 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that makes getting shots in my muscles unsafe.I have an autoimmune disorder or a condition that weakens my immune system.My neurological condition is under control as per my doctor's assessment.I have not received, nor do I plan to receive, a specific flu vaccine outside the study's guidelines.I live independently or in a place where I mostly take care of myself.I am currently experiencing or have tested positive for a herpes zoster outbreak.I am planning to become pregnant or stop using birth control.I am bedridden.I have received or plan to receive the Shingrix vaccine.I have not had the Zostavax vaccine in the last 2 years.I haven't taken long-term immune system drugs recently.I have not received immunoglobulins or blood products recently.I have not used any experimental treatments recently.I have not received any vaccines not approved by the study recently.I am a woman who cannot become pregnant.I haven't taken long-acting immune drugs recently.I am 50 years old or older.I have been vaccinated against RSV before.I have a condition that significantly affects my thinking or memory.I am a woman who can have children, using birth control, not pregnant, and agree to keep using birth control.I have had Guillain-Barré syndrome in the past.
Research Study Groups:
This trial has the following groups:- Group 1: RSV+ HZ/su Co-administration Group
- Group 2: RSV+HZ/su Control 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree might Co-administration be hazardous to individuals?
"Co-administration has been established as safe and effective, consequently receiving a score of 3 on our team's scale. This is due to the trial in question being a phase 3 study, indicating that there are both efficacy data and multiple safety assessments associated with it."
Answered by AI
Has the trial been extended to various medical facilities within the United States?
"This clinical trial has opened recruitment in 23 different sites, including Tempe, Corte Madera and Aurora. It is recommended that participants choose the closest site to minimise any travel obligations should they decide to enrol."
Answered by AI
Is participation in this research endeavor still open to volunteers?
"Per the information provided by clinicaltrials.gov, this research project is not currently enrolling participants. The trial was initiated on August 8th 2023 and was last revised on July 21st 2023; however, there are 49 other trials that require subjects at present."
Answered by AI
Who else is applying?
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
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