RSVPreF3 OA investigational vaccine for Respiratory Syncytial Virus Infections

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Respiratory Syncytial Virus Infections
RSVPreF3 OA investigational vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess the safety and long-term effectiveness of a new RSV vaccine in adults aged 60+. The study will also evaluate the safety and effectiveness of additional doses of the vaccine given at different intervals.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Respiratory Syncytial Virus Infections

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: From revaccination (Month 24) up to 6 months post-revaccination (Month 30)

At Day 1 (pre-vaccination)
Humoral immune response in terms of RSV-A neutralizing antibody Geometric Mean Titers (GMTs)
Humoral immune response in terms of RSVPreF3 Immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs)
At Day 1(pre-vaccination)
CMI response in terms of frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ and/or CD8+ T cells expressing at least 2 activation markers
At Month 25
CMI response in terms of frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers
Antibodies, Blocking
Humoral immune response in terms of RSV-B neutralizing antibody titers
Humoral immune response in terms of RSVPreF3 IgG antibody GMCs
Day 30
Number of participants with any unsolicited adverse events (AEs)
Month 24
Number of participants with any unsolicited AEs
Month 24
Number of participants with at least one solicited administration-site event and solicited systemic event
Month 6
Number of participants reporting any potential immune-mediated disease (pIMD)
Number of participants with serious adverse events (SAE)
Month 36
Number of participants with a fatal SAE, related SAE and related pIMDs
Month 30
Number of participants reporting any pIMD
Number of participants with SAEs

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Respiratory Syncytial Virus Infections

Side Effects for

Co-Ad Group
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%Oropharyngeal pain
1%Upper respiratory tract infection
1%Nausea
1%Decreased appetite
1%Pain
1%Death
1%Epistaxis
1%Neck pain
1%Back pain
1%Injection site bruising
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT04841577) in the Co-Ad Group ARM group. Side effects include: Injection site pain with 53%, Fatigue with 23%, Headache with 22%, Myalgia with 22%, Arthralgia with 17%.

Trial Design

3 Treatment Groups

Group B
1 of 3
Group A
1 of 3
Group C
1 of 3
Experimental Treatment

1720 Total Participants · 3 Treatment Groups

Primary Treatment: RSVPreF3 OA investigational vaccine · No Placebo Group · Phase 3

Group B
Biological
Experimental Group · 1 Intervention: RSVPreF3 OA investigational vaccine · Intervention Types: Biological
Group A
Biological
Experimental Group · 1 Intervention: RSVPreF3 OA investigational vaccine · Intervention Types: Biological
Group C
Biological
Experimental Group · 1 Intervention: RSVPreF3 OA investigational vaccine · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVPreF3 OA investigational vaccine
2021
Completed Phase 3
~1740

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from revaccination (month 24) up to 6 months post-revaccination (month 30)

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,635 Previous Clinical Trials
7,940,762 Total Patients Enrolled
27 Trials studying Respiratory Syncytial Virus Infections
53,377 Patients Enrolled for Respiratory Syncytial Virus Infections

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.