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Virus Therapy

COVID-19 Vaccine + RSV Vaccine for Adults 50+

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
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

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~at pre-vaccination (day 1 for co-ad group and day 31 for control) and 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 pre-vaccination (day 1 for co-ad group and day 31 for control) 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
RSV-A neutralization titers
RSV-B neutralization titers
SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein
Secondary outcome measures
Percentage of participants having RSV-A neutralizing titers >= assay cut-off value
Percentage of participants having RSV-B neutralizing titers >= assay cut-off value
Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value
+13 more

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
COVID-19 mRNA vaccine
2021
Completed Phase 2
~480
RSVPreF3 OA investigational vaccine
2021
Completed Phase 3
~4320

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,772 Previous Clinical Trials
8,106,053 Total Patients Enrolled
~486 spots leftby Dec 2024