COVID-19 Vaccine + RSV Vaccine for Adults 50+

Recruiting at 24 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must not be taking: Immune-modifying drugs

Disqualifiers: Immunodeficient, Neurological disorders, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 month

842 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.

Eligibility Criteria

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.

Inclusion Criteria

Written or witnessed informed consent obtained from the participant prior to any study-specific procedure

Participants must be able and willing to comply with the protocol requirements, including completion of diary cards and follow-up visits

I am 50 years old or older.

Exclusion Criteria

I am scheduled to receive vaccines at specific times.

Use of any investigational or non-registered product during specified periods

Participation of study personnel, their dependents, family, or household members

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of RSVPreF3 OA investigational vaccine and a single dose of COVID-19 mRNA vaccine at Day 1 for Co-Ad Group, and a single dose of COVID-19 mRNA vaccine at Day 1 followed by a single dose of RSVPreF3 OA investigational vaccine at Day 31 for Control Group

1 month

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of immunogenicity, safety, and reactogenicity

6 months

Treatment Details

Interventions

• COVID-19 mRNA vaccine
• RSVPreF3 OA investigational vaccine

Trial Overview 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.

Participant Groups

Group I: Co-Ad Group Experimental Treatment 2 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 Group Active Control 2 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).

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School