Combination Vaccine for Flu and COVID-19

No longer recruiting at 24 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: Immune-modifying drugs, others

Disqualifiers: Pregnancy, Immunodeficiency, Cancer, others

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

Compensation: Varies

Number of Visits: 27

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination vaccine targeting both flu and COVID-19, focusing on safety and immune response effectiveness. The flu component protects against multiple strains, while the COVID-19 component targets the virus's spike protein. This marks the first time both vaccines are combined and tested together in humans. Ideal participants are healthy adults who have already received a COVID-19 vaccination and have not recently had the flu. As a Phase 1 trial, participants will be among the first to receive this innovative treatment, aiding researchers in understanding its effects in humans.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot use investigational products, certain vaccines, or immune-modifying drugs close to the study period. It's best to discuss your specific medications with the study investigator.

Do I need 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, you cannot use any investigational products or certain immune-modifying drugs during the study. It's best to discuss your specific medications with the study team.

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

Studies have shown that the investigational flu/COVID-19 combination vaccine, like Moderna's mRNA-1083, is well-tolerated when each component is tested separately. Research indicates that this combined vaccine triggers strong immune responses to both flu and COVID-19. Earlier trials for similar combination vaccines have demonstrated good safety results, with no major safety concerns.

Most side effects have been mild, such as sore arms or slight fevers, similar to typical reactions from separate flu or COVID-19 shots. Since both components of the vaccine have undergone individual testing, their combined use is expected to be safe. However, as this is an early-stage trial, ongoing monitoring for any new safety information remains crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the investigational flu and COVID-19 combination vaccine because it has the potential to simplify and enhance protection against both viruses in a single shot. Unlike the current standard of care, which involves separate vaccines for flu and COVID-19, this combination vaccine merges them, potentially increasing convenience and compliance. Furthermore, using mRNA technology, which has been highly effective in COVID-19 vaccines, could also improve the efficiency and adaptability of flu vaccines, offering more robust and rapid responses to new strains.

What evidence suggests that this trial's combination vaccine could be effective for flu and COVID-19?

Research has shown that the new Flu Seasonal/SARS-CoV-2 combination vaccine, mRNA-1083, appears promising. In this trial, participants in the mRNA Flu/COVID-19 Dose 1 Group and mRNA Flu/COVID-19 Dose 2 Group will receive this investigational combination vaccine. Studies have found that this vaccine can generate strong immune responses against both the flu and COVID-19. For older adults, it even produced stronger immune responses than regular flu vaccines. The vaccine performs as well as receiving separate flu and COVID-19 vaccines. However, some trials reported mixed results, so its effectiveness might vary. Overall, evidence suggests that this combined vaccine could effectively protect against both viruses. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults who are interested in receiving a combination vaccine that targets both the flu and COVID-19. Specific eligibility criteria were not provided, but typically participants should not have conditions that could interfere with the study or pose additional health risks.

Inclusion Criteria

Written informed consent must be obtained from the participant before any study-specific procedure

I am healthy or have a stable condition as confirmed by medical exams.

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

Exclusion Criteria

Positive influenza test within 180 days prior to Day 1

Conditions precluding assessment of local reactogenicity at the injection site

Planned move during the study period that would hinder study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one dose of the investigational Flu Seasonal/SARS-CoV-2 mRNA vaccine or comparator vaccines on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Multiple visits (in-person and virtual) over 26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine

Trial Overview The trial is testing a new combo vaccine for flu and COVID-19. It's looking at how people react to it, its safety, and if it triggers an immune response. The study will compare different doses of this combined mRNA vaccine against separate flu and COVID-19 vaccines.

How Is the Trial Designed?

Group I: mRNA Flu/COVID-19 Dose 2 Group Experimental Treatment 2 Interventions

Participants receive one dose of a Flu mRNA vaccine composition in combination with a Dose 2 of a COVID-19 component and 1 dose of placebo on Day 1.

Group II: mRNA Flu/COVID-19 Dose 1 Group Experimental Treatment 2 Interventions

Participants receive one dose of investigational Flu mRNA vaccine composition in combination with a Dose 1 of a COVID-19 component and 1 dose of placebo on Day 1.

Group III: Flu+COVID-19 Group Active Control 2 Interventions

Participants receive one dose of a licensed Flu Seasonal vaccine and a licensed mRNA COVID-19 vaccine on Day 1.

Group IV: mRNA Flu Group Active Control 2 Interventions

Participants receive one dose of an investigational mRNA Flu Seasonal vaccine and 1 dose of placebo on Day 1.

Group V: mRNA COVID-19 Dose 2 Group Active Control 2 Interventions

Participants receive one Dose 2 investigational mRNA COVID-19 vaccine and 1 dose of placebo on Day 1.

Group VI: mRNA COVID-19 Dose 1 Group Active Control 2 Interventions

Participants receive one dose of Dose 1 investigational mRNA COVID-19 vaccine and 1 dose of placebo on Day 1.

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

Published Research Related to This Trial

A new combination vaccine platform has been developed that incorporates a part of the SARS-CoV-2 spike protein onto influenza A virus particles, which successfully elicited neutralizing antibodies and protected mice from both viruses.

This approach leverages existing influenza vaccine production infrastructure, potentially allowing for a cost-effective and scalable seasonal vaccine that can be easily reformulated to address emerging variants of both influenza and SARS-CoV-2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virion-Based Combination Vaccine Protects against Influenza and SARS-CoV-2 Disease in Mice. Chaparian, RR., Harding, AT., Hamele, CE., et al.[2023]

A review of 12 studies found no significant increase in the risk of SARS-CoV-2 infection or severe illness among COVID-19 patients who received the seasonal influenza vaccine.

Some studies even suggested that influenza vaccination may be associated with a lower risk of severe outcomes, supporting the promotion of flu vaccination to improve overall health during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between Influenza Vaccination and the Risk of SARS-CoV-2 Infection, Severe Illness, and Death: A Systematic Review of the Literature. Del Riccio, M., Lorini, C., Bonaccorsi, G., et al.[2020]

The substudy involving 431 participants demonstrated that co-administering the COVID-19 vaccine NVX-CoV2373 with seasonal influenza vaccines was generally safe, with no serious adverse events or anaphylaxis reported, although reactogenicity (like tenderness and fatigue) was higher in the co-vaccination group.

The efficacy of NVX-CoV2373 in the substudy was 87.5%, which is comparable to the main study's efficacy of 89.8%, indicating that co-administration does not significantly compromise the effectiveness of the COVID-19 vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial. Toback, S., Galiza, E., Cosgrove, C., et al.[2022]

The TACTIC study found that while it is safe to administer the mRNA COVID-19 booster and the influenza vaccine concurrently, the immune response (measured by antibody levels) was lower compared to receiving the COVID-19 booster alone, indicating potential reduced protection against COVID-19.

In a trial involving 154 participants aged 60 and older, the concurrent administration did not meet the non-inferiority criteria for antibody response, suggesting that while side effects were mild and similar across groups, further research is needed to fully understand the implications of co-vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing and sequence of vaccination against COVID-19 and influenza (TACTIC): a single-blind, placebo-controlled randomized clinical trial. Dulfer, EA., Geckin, B., Taks, EJM., et al.[2023]

The study involving 306 older adults (aged 65 and above) found that administering the high-dose quadrivalent influenza vaccine (QIV-HD) alongside the mRNA-1273 COVID-19 booster was safe, with no serious adverse events reported and similar reactogenicity profiles to the mRNA-1273 vaccine alone.

Both vaccines effectively increased antibody responses against influenza strains and SARS-CoV-2, indicating that co-administration does not interfere with immune responses, supporting the recommendation for simultaneous vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a high-dose quadrivalent influenza vaccine administered concomitantly with a third dose of the mRNA-1273 SARS-CoV-2 vaccine in adults aged ≥65 years: a phase 2, randomised, open-label study. Izikson, R., Brune, D., Bolduc, JS., et al.[2022]

Healthcare workers who received the bivalent COVID-19 mRNA booster and the influenza vaccine on the same day showed higher antibody responses to SARS-CoV-2 compared to those who received them on separate days.

The study suggests that administering both vaccines concurrently not only enhances peak immunogenicity but also leads to more durable antibody responses over a 6-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent administration of COVID-19 and influenza vaccines enhances Spike-specific antibody responses. Barouch, SE., Chicz, TM., Blanc, R., et al.[2023]

In a study involving 248 adults, coadministration of the seasonal influenza vaccine (SIV) with COVID-19 vaccines resulted in mostly mild adverse events, indicating that the combination is generally safe.

The frequency of moderate to severe adverse events was similar between those receiving SIV and those receiving a placebo, suggesting that there is no need to separate the administration of SIV and COVID-19 vaccines in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single blinded, phase IV, adaptive randomised control trial to evaluate the safety of coadministration of seasonal influenza and COVID-19 vaccines (The FluVID study). Ramsay, JA., Jones, M., Vande More, AM., et al.[2023]

Citations

1. nature.com nature.com/articles/s41541-025-01145-6

Comparing Moderna's mRNA-1083 and Pfizer's dual- ... Moderna has reported promising trial results for mRNA-1083, showing strong immune responses against both SARS-CoV-2 and influenza antigens with ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2823803

Combo COVID-19 and Flu mRNA Vaccine Falls Short of ... A phase 3 clinical trial evaluating the safety and efficacy of a messenger RNA (mRNA) combination vaccine for COVID-19 and influenza had mixed results.

3. pulmonologyadvisor.com pulmonologyadvisor.com/news/moderna-withdraws-bla-for-flu-covid-19-combo-vaccine-candidate/

Moderna Withdraws BLA for Flu/COVID-19 Combo Vaccine ... Recently published findings showed mRNA-1083 was noninferior to standard influenza and COVID-19 vaccines and induced higher immune responses ...

4. cidrap.umn.edu cidrap.umn.edu/covid-19/combo-flu-covid-vaccine-shows-good-immune-response-safety-older-adults

Combo flu-COVID vaccine shows good immune response, ... For all ages, mRNA-1083, the combined vaccine, elicited higher immune responses than the standard-dose flu vaccine given to those 50 to 64 years ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12238597/

Progress in combination vaccines and the co-administration of ... Current clinical data now provide robust evidence for evaluating the outcomes of co-administration of influenza and SARS-CoV-2 vaccines.

6. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-mrna-based-combination

Pfizer and BioNTech Provide Update on mRNA-based ... The combination candidate consists of Pfizer's mRNA-based influenza vaccine candidate with the companies' licensed COVID-19 vaccine.

7. trials.modernatx.com trials.modernatx.com/study/?id=mRNA-1083-P301

Seasonal flu and COVID-19 are respiratory illnesses The Duo P301 Trial will assess the safety and immune response of an investigational combination vaccine, called mRNA-1083, aimed at preventing seasonal flu ...