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Virus Therapy
RSV + PCV20 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 within 7 days (the day of vaccination and 6 subsequent days) after each vaccine (administered on day 1 and day 31)
Awards & highlights
Study Summary
This trial studies if a vaccine combo can protect older adults against disease and is safe.
Who is the study for?
This trial is for adults aged 60 or older who are generally healthy, can care for themselves, and have stable chronic conditions. They must be willing to follow the study rules and not have immune deficiencies, severe allergies to certain vaccines, unstable chronic illnesses, cognitive impairments, or a history of drug abuse.Check my eligibility
What is being tested?
The study tests how well an experimental RSV vaccine (RSVPreF3 OA) works with another vaccine called PCV20 in people over 60. It looks at the immune response generated and safety when these two vaccines are given together.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, chills or fever. Severe allergic reactions are rare but possible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 7 days (the day of vaccination and 6 subsequent days) after each vaccine (administered on day 1 and day 31)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days (the day of vaccination and 6 subsequent days) after each vaccine (administered on day 1 and day 31)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opsonophagocytic (OP) antibody (Ab) titers for each of the pneumococcal vaccine serotype (ST)
RSV-A neutralizing Ab titers
RSV-B neutralizing Ab titers
Secondary outcome measures
Percentage of participants reporting each solicited administration site adverse event (AE)
Percentage of participants reporting each solicited systemic AE
Percentage of participants reporting potential immune mediated diseased (pIMDs)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Co-ad GroupExperimental Treatment2 Interventions
Participants receive both the RSVPreF3 OA investigational vaccine and the PCV20 vaccine on Day 1.
Group II: Control GroupActive Control2 Interventions
Participants receive the PCV20 vaccine on Day 1 and the RSVPreF3 OA investigational vaccine on Day 31.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PCV20
2022
Completed Phase 3
~2670
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
8,066,339 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a pneumococcal vaccine in the last 5 years.I am 60 years old or older.I have been vaccinated against RSV before.I have a condition or treatment that weakens my immune system.I haven't received and don't plan to get certain flu shots around my study treatment dates.I have been vaccinated with a pneumococcal vaccine before or plan to through this study.I am not taking or planning to take long-acting immune drugs during the study.I haven't received immunoglobulins or blood products in the last 90 days.I haven't received vaccines not in the study, except COVID-19 or flu shots as per guidelines.I have a condition that significantly affects my thinking or memory.I am bedridden.I live independently or in a place where I mostly take care of myself.I have a serious or unstable chronic illness.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.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Co-ad 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: NCT05879107 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical investigation admitting new participants at the present time?
"Affirmative. The information on clinicaltrials.gov suggests that this clinicial trial is actively recruiting patients, with the original posting date of May 26th 2023 and most recent update occurring June 23rd 2023. This medical investigation requires 1090 volunteers from 40 distinct locations."
Answered by AI
How many individuals are partaking in this research endeavor?
"Affirmative. The clinicaltrials.gov website reveals that this experiment, initially published on May 26th 2023, is currently recruiting participants. 40 medical centres are searching for 1090 individuals to join the trial."
Answered by AI
Does the Co-ad Group have regulatory authorization from the FDA?
"There is a wealth of evidence that Co-ad Group treatment has been safely administered, so it was graded at 3 on our scale."
Answered by AI
To what extent are there numerous sites running this clinical trial in state?
"This trial is currently taking place in 40 distinct sites, which include Huntington Beach, Troy and Saint Louis. Therefore, it's essential to choose the nearest centre if you wish to minimize travel requirements as a study participant."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
Texas
What site did they apply to?
GSK Investigational
GSK Investigational Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to help science and other people.
PatientReceived 2+ prior treatments
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