Combination Vaccine for Flu and COVID-19

Recruiting at 23 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

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

107 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the reactogenicity, safety, and immune response of Flu Seasonal/SARS-CoV-2 mRNA (mRNA Flu/COVID-19) combination vaccine. The flu portion will target multiple strains of the flu virus, while the COVID-19 part will focus on the spike protein of the SARS-CoV-2 virus. Both parts of this vaccine have been tested individually before. This will be the first study to test the combined vaccine in humans in healthy adult participants.

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.

What data supports the idea that Combination Vaccine for Flu and COVID-19 is an effective treatment?

The available research shows that a combination vaccine for flu and COVID-19 can be effective. In a study with mice, the vaccine provided protection against both influenza and COVID-19, suggesting it could be a practical solution for boosting immunity to these viruses. Additionally, studies have shown that administering flu and COVID-19 vaccines together is safe and can maximize protection, especially in older adults. This means the combination vaccine could help protect people from both diseases without needing separate shots. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Combination Vaccine for Flu and COVID-19?

Research shows that combining flu and COVID-19 vaccines can be safe and effective. A study found that a combination vaccine in mice produced protective antibodies against both flu and COVID-19, suggesting it could offer protection against both diseases. ^{1 2 3 4 5}

What safety data exists for the combination flu and COVID-19 vaccine?

The safety data for the combination flu and COVID-19 vaccine includes studies on the co-administration of COVID-19 and influenza vaccines. These studies generally show that co-administration is safe, with no significant increase in adverse events. For example, a phase 3 trial evaluated the safety of NVX-CoV2373 with seasonal flu vaccines, and a phase 2 study assessed the safety of a high-dose flu vaccine with an mRNA-1273 booster in older adults. Additionally, a phase IV trial (The FluVID study) examined the safety of co-administering flu and COVID-19 vaccines, supporting the practice as safe. Animal studies also suggest that combination vaccines can be effective and safe, providing protection against both influenza and SARS-CoV-2 in mice. ^{1 2 3 4 6}

Is the combination vaccine for flu and COVID-19 safe for humans?

Research shows that giving flu and COVID-19 vaccines together is generally safe, with no significant increase in severe side effects. Studies in older adults and other trials have found that combining these vaccines does not lead to more serious health issues. ^{1 2 3 4 6}

Is the combination vaccine for flu and COVID-19 a promising treatment?

Yes, the combination vaccine for flu and COVID-19 is promising because it can protect against both diseases with one shot. It uses existing flu vaccine technology, making it cost-effective and easy to produce. It also boosts immunity effectively, which is important as new virus variants emerge. ^{1 2 3 5 7}

How is the investigational flu and COVID-19 combination vaccine different from other treatments?

The investigational flu and COVID-19 combination vaccine is unique because it combines protection against both influenza and SARS-CoV-2 in a single shot, potentially using existing flu vaccine infrastructure to make it cost-effective and scalable. This approach may simplify vaccination schedules and enhance convenience compared to receiving separate vaccines for each virus. ^{1 2 3 5 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Virion-Based Combination Vaccine Protects against Influenza and SARS-CoV-2 Disease in Mice. [2023]

3. England 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. [2022]

4. Switzerland 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. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Timing and sequence of vaccination against COVID-19 and influenza (TACTIC): a single-blind, placebo-controlled randomized clinical trial. [2023]

6. Netherlands 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). [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Concurrent administration of COVID-19 and influenza vaccines enhances Spike-specific antibody responses. [2023]