Co-Ad Group for Respiratory Syncytial Virus Infections

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Respiratory Syncytial Virus Infections
FLU HD vaccine - Biological
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)

Month 1
HI antibody titers for each of the FLU vaccine strains, expressed as MGI
HI seroconversion rate (SCR) for each of the FLU vaccine strains
Hemagglutinin inhibition (HI) antibody titers for each of the FLU vaccine strains, expressed as group GMT ratio
Month 1
RSV-A neutralization antibody titers expressed as group geometric mean titer (GMT) ratio
Antibodies, Blocking
RSV-B neutralization antibody titers expressed as MGI
Antibodies, Blocking
Month 1
HI antibody titers for each of the FLU vaccine strains, expressed as GMT
HI seroprotection rate (SPR) for each of the FLU vaccine strains
Month 6
Percentage of participants with pIMDs
Percentage of participants with serious adverse events (SAEs)
Day 30
Percentage of participants with unsolicited adverse events (AEs) (potential immune-mediated disease (pIMD), non-serious AE or serious AE)
Day 4
Percentage of participants with solicited administration site events
Percentage of participants with solicited systemic events

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Control Group
1 of 2
Co-Ad Group
1 of 2

Active Control

Experimental Treatment

1028 Total Participants · 2 Treatment Groups

Primary Treatment: Co-Ad Group · No Placebo Group · Phase 3

Co-Ad GroupExperimental Group · 2 Interventions: FLU HD vaccine, RSVPreF3 OA investigational vaccine · Intervention Types: Biological, Biological
Control GroupActiveComparator Group · 2 Interventions: FLU HD vaccine, RSVPreF3 OA investigational vaccine · Intervention Types: Biological, 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

Screening: ~3 weeks
Treatment: Varies
Reporting: within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on day 1 and 31)

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,640 Previous Clinical Trials
7,944,409 Total Patients Enrolled
27 Trials studying Respiratory Syncytial Virus Infections
54,069 Patients Enrolled for Respiratory Syncytial Virus Infections

Eligibility Criteria

Age 65+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 65 years of age or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: November 1st, 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.