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Virus Therapy

RSVPreF3 OA investigational 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 at 30 days post-vaccination (day 31)
Awards & highlights

Study Summary

This study is evaluating whether a vaccine can be made consistently and safely.

Eligible Conditions
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 days post-vaccination (day 31)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days post-vaccination (day 31) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
RSVPreF3 Specific Immunoglobin (Ig)G Antibody Concentrations Expressed as Group Geometric Mean Concentration (GMC)
Secondary outcome measures
Percentage of Participants Reporting Solicited Administration Site Events
Percentage of Participants Reporting Solicited Systemic Events
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)
+3 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

3Treatment groups
Experimental Treatment
Group I: RSV OA_Lot 3Experimental Treatment1 Intervention
Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
Group II: RSV OA_Lot 2Experimental Treatment1 Intervention
Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).
Group III: RSV OA_Lot 1Experimental Treatment1 Intervention
Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).
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
4,753 Previous Clinical Trials
8,068,688 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above
2021. "A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05059301.
~220 spots leftby Apr 2025
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