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Cancer Vaccine

RSV-A-AIR Group for Respiratory Syncytial Virus

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
Female participants of non-childbearing potential
Male or female participant 18-49 YOA at the time of the study intervention administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month (day 31) post-rsvpref3 oa investigational vaccine dose administration compared to baseline (day 1)
Awards & highlights

Study Summary

This trial aims to test a new vaccine for respiratory syncytial virus in adults aged 18-49 years who are at risk for the disease, compared to older adults aged 60 years and above

Who is the study for?
This trial is for non-immunocompromised adults aged 18-49 at increased risk for RSV disease, and older adults aged 60+. Key eligibility details are not provided, so interested individuals should contact the study organizers for full inclusion and exclusion criteria.Check my eligibility
What is being tested?
The study tests the immune response and safety of an investigational vaccine called RSVPreF3 OA. It compares how younger adults (18-49) at higher risk respond to the vaccine versus those who are older (60+).See study design
What are the potential side effects?
Specific side effects aren't listed here, but typically vaccines may cause reactions like soreness at injection site, fever, fatigue or mild flu-like symptoms. Participants will be monitored for any adverse responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot become pregnant.
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I am between 18 and 49 years old.
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I am 60 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month (day 31) post-rsvpref3 oa investigational vaccine dose administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month (day 31) post-rsvpref3 oa investigational vaccine dose administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR)
RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR)
SRR in RSV-B neutralizing titers
+1 more
Secondary outcome measures
Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF)
Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs
Percentage of participants reporting solicited administration site events
+4 more

Side effects data

From 2022 Phase 3 trial • 976 Patients • NCT04841577
53%
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

2Treatment groups
Experimental Treatment
Group I: RSV-OA GroupExperimental Treatment1 Intervention
Older adults (OA) participants, >=60 YOA, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).
Group II: RSV-A-AIR GroupExperimental Treatment1 Intervention
Adult participants, 18-49 YOA, at increased risk (AIR) for RSV disease, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).
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
4,763 Previous Clinical Trials
8,103,863 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different sites is this medical trial being administered?

"At the moment, this research study is actively enrolling participants from a network of 43 sites. Notable locations include Sherbrooke in Québec and Mainz among others. To reduce travel commitments, it is advisable to choose a site that is conveniently located for you."

Answered by AI

Has the RSV-A-AIR Group received FDA authorization for use?

"Our assessment at Power rates the safety of RSV-A-AIR Group as a 3 on our scale. This determination is based on the trial being in Phase 3, which implies there is existing evidence supporting its effectiveness and numerous rounds of data backing its safety profile."

Answered by AI

Is the enrollment phase for this investigation currently ongoing?

"Information from clinicaltrials.gov states that patient enrollment for this trial is currently closed. Although the study was initially listed on May 10, 2024, the latest update occurred on April 24, 2024. Despite this particular trial not accepting participants, there are approximately 135 other studies available for enrollment presently."

Answered by AI

What is the primary objective of this clinical trial?

"As per GlaxoSmithKline, the primary endpoint of interest in this study will be the RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) at 1 month following administration of the experimental vaccine dose. Secondary outcomes include evaluating solicited systemic events such as fever, headache, myalgia, arthralgia, and fatigue. Fever is characterized by a temperature equal to or exceeding 38.0 degrees Celsius/100.4 degrees Fahrenheit regardless of measurement location which can be oral or axillary., measuring RSV-A neutralizing titers displayed as GMTs with"

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Want to try the study.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above
2024. "A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06389487.
All > Rsv > Knoxville
~567 spots leftby Aug 2024
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