COVID-19 Vaccine + RSV Vaccine for Adults 50+

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

Research Team

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

Treatment Details

Interventions

• COVID-19 mRNA vaccine (Virus Therapy)
• RSVPreF3 OA investigational vaccine (Virus Therapy)

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