COVID-19 Vaccine + RSV Vaccine for Adults 50+

No longer recruiting at 27 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of a new RSV vaccine when administered alongside a COVID-19 vaccine. Researchers seek to determine if taking both vaccines together is as effective and safe as taking them separately. The trial is recruiting adults aged 50 and older who received a COVID-19 vaccine at least three months ago and have stable health conditions, such as well-managed diabetes or high blood pressure. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new vaccine combination.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on immune-modifying drugs or have had certain treatments recently, you might not be eligible. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the COVID-19 mRNA vaccine and the RSVPreF3 OA investigational vaccine have been studied for safety in adults. The COVID-19 mRNA vaccines have been widely used and are generally well-tolerated, with common side effects like sore arms and fatigue.

The RSVPreF3 OA vaccine has also undergone testing in other studies. It received approval in 2023 for adults in Europe, meeting safety standards. Some studies suggest it can cause mild side effects, such as injection site pain or mild flu-like symptoms.

When administered together, research indicates these vaccines are generally safe for individuals aged 50 and above. Some might experience minor side effects, but serious issues are rare. Overall, the safety data appears favorable for both vaccines, whether given alone or together. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining the COVID-19 mRNA vaccine with the RSVPreF3 OA investigational vaccine because it targets two significant respiratory viruses simultaneously, potentially enhancing immune protection for adults over 50. Unlike traditional vaccines that address a single virus, this combination aims to streamline protection with a single visit, which could increase convenience and compliance. The innovative approach of administering both vaccines together could lead to more efficient and widespread immunization strategies, reducing the overall burden of respiratory illnesses in this age group.

What evidence suggests that this trial's treatments could be effective for adults 50+?

Research has shown that the COVID-19 mRNA vaccine for the Omicron XBB.1.5 variant is effective, with studies indicating it reduces the risk of hospitalization by 46%. Nearly half of vaccinated older adults were protected from severe illness. Trials have demonstrated that the RSVPreF3 OA vaccine can effectively prevent respiratory syncytial virus (RSV) infection in older adults, with an effectiveness rate between 83.7% and 88.9%. In this trial, participants in the Co-Ad Group will receive both vaccines on Day 1, while those in the Control Group will receive the COVID-19 mRNA vaccine on Day 1 and the RSVPreF3 OA vaccine on Day 31. These vaccines are designed to strengthen the immune system, helping older adults guard against both COVID-19 and RSV. These findings suggest that these vaccines could be very effective for the study participants. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06374394

NCT06374394 | A Study on the Immune Response and ... This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMsa2514268

Updated Evidence for Covid-19, RSV, and Influenza ... Covid-19 mRNA vaccines against the XBB.1.5 subvariant had pooled vaccine effectiveness against hospitalization of 46% (95% confidence interval [ ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25006875

Older adults' and physicians' preferences for respiratory ... Older adults aged 60–69 years with chronic conditions associated with increased risks of RSV were most likely to accept RSV vaccination (85 %).

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11627484/

RSV vaccination as the optimal prevention strategy for ... This paper will report efficacy and safety data for the three main vaccines currently available for healthcare practitioners.

5. adultimmunizationboard.org adultimmunizationboard.org/wp-content/uploads/2025/05/RSV-Specific-topic-Need-for-revaccination-When-and-how-to-organize-it.pdf

Elisabeth BOTELHO- NEVERS Vaccine efficacy / effectiveness in older adults. Efficacy from 88.9% to 83.7% according to different primary outcomes. Effectiveness USA from Abrysvo®+ ...

6. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(24)00589-9/fulltext

Safety and immunogenicity of mRNA-1345 RSV vaccine ... Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05590403

NCT05590403 | A Study on the Immune Response and ... A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased ...