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Virus Therapy

COVID-19 Vaccine + RSV Vaccine for Adults 50+

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

Female participants of non-childbearing potential

Be older than 18 years old

Must not have

History of myocarditis or pericarditis

Recurrent or uncontrolled neurological disorders or seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month post-covid-19 mrna vaccine dose administration (at day 31) compared to pre-vaccination (at day 1)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will look at how well a new vaccine works and how safe it is when given together with a COVID-19 vaccine, compared to when the vaccines are given separately in adults who are 50

Who is the study for?

This trial is for adults aged 50 and above who are interested in receiving vaccines against both RSV (Respiratory Syncytial Virus) and COVID-19. Participants should not have any health conditions that the study team thinks could interfere with the trial results or pose a risk.

What is being tested?

The study is testing how well an investigational RSV vaccine works when given at the same time as a new COVID-19 mRNA vaccine, compared to giving them separately. It's looking at immune response and safety of these vaccinations in older adults.

What are the potential side effects?

Possible side effects may include typical reactions to vaccines such as soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea. The exact side effects will be monitored closely throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had myocarditis or pericarditis in the past.

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I have recurring or uncontrolled seizures or neurological disorders.

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I have a history of dementia or cognitive issues.

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I am pregnant, breastfeeding, or planning to become pregnant.

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I am bedridden.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month post-rsvpref3 oa investigational vaccine dose administration (day 31 for co-ad group and day 61 for control group)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month post-rsvpref3 oa investigational vaccine dose administration (day 31 for co-ad group and day 61 for control group)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month post-rsvpref3 oa investigational vaccine dose administration (day 31 for co-ad group and day 61 for control group) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

RSV-A neutralization titers

RSV-B neutralization titers

SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein

Secondary study objectives

Percentage of participants reporting each solicited administration site event

Percentage of participants reporting each solicited systemic event

Percentage of participants reporting potential immune-mediated diseases (pIMDs)

+10 more

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Co-Ad GroupExperimental Treatment2 Interventions

Participants receive a single dose of RSVPreF3 OA investigational vaccine and a single dose of COVID-19 mRNA vaccine at Day 1 and are followed up until end of study (6 months post last dose).

Group II: Control GroupActive Control2 Interventions

Participants receive a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA investigational vaccine at Day 31 and are followed up until end of study (6 months post last dose).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSVPreF3 OA investigational vaccine

2023

Completed Phase 3

~5970

COVID-19 mRNA vaccine

2021

Completed Phase 2

~630