Combination Vaccine for COVID-19 and Flu

Not currently recruiting at 14 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Immunodeficiency, Bleeding disorder, Stroke, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 2

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 for COVID-19 and the flu to assess its safety and ability to build immunity. Participants will receive varying doses of the combo vaccine or separate vaccines for comparison. The trial seeks individuals aged 50 and older who are healthy or have stable health conditions and have received their COVID-19 shots and a booster. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking vaccine development.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or long-term systemic corticosteroids, you may not be eligible to participate.

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

Research has shown that the rC19 vaccine, used to prevent COVID-19, has generally been well tolerated in earlier studies. However, some reports have noted rare side effects, such as myocarditis and pericarditis, which involve inflammation of the heart or surrounding tissue.

Early results suggest that combining the rC19 vaccine with the recombinant influenza vaccine (RIV) is also well tolerated. Previous trials found no new safety issues, and participants responded well to the vaccines. Adjusting the dose has ensured both good tolerance and a strong immune response.

Overall, current data indicates that the treatment is well tolerated, but staying updated on any new findings as the trial continues is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination vaccine for COVID-19 and flu because it aims to tackle both viruses with a single shot, potentially simplifying and enhancing immunization efforts. Unlike separate vaccines for COVID-19 and the flu, this combination treatment could streamline the vaccination process, making it more convenient for patients and healthcare providers alike. The vaccine pairs the recombinant COVID-19 protein (rC19) and the recombinant influenza vaccine (RIV), which might boost immune response efficiency compared to taking separate vaccines. This innovative approach could also potentially improve compliance rates and overall public health outcomes by offering broader protection in a single appointment.

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

This trial will evaluate different vaccine combinations for COVID-19 and flu. Studies have shown that both the separate flu and COVID-19 vaccines, as well as the combination vaccine, effectively boost immunity against these viruses. Participants in this trial may receive the combination vaccine, which includes both the flu and COVID-19 components and has increased immune responses by 2.4 to 5.7 times compared to initial levels. Research indicates that the COVID-19 vaccine, Nuvaxovid, is highly effective, with success rates between 89.7% and 90.4% in preventing COVID-19 infections. Additionally, other studies suggest that a combined vaccine might trigger stronger immune responses than receiving each vaccine separately. Overall, these findings suggest that the combination vaccine may effectively enhance protection against both COVID-19 and the flu. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 50 or older in the U.S. who can get shots in both arms, have completed their initial COVID-19 vaccine series plus a booster, and are either not able to have children or agree to use contraception. They should be healthy or with stable pre-existing conditions.

Inclusion Criteria

I am 50 years old or older.

Informed consent form has been signed and dated

I am not pregnant or breastfeeding and follow specific birth control guidelines.

Exclusion Criteria

I haven't had recent vaccines or received immune globulins/blood products.

Known systemic hypersensitivity to study intervention components or history of life-threatening reactions to study interventions

Substance abuse that might interfere with study conduct or completion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two intramuscular injections on Day 01, one in each deltoid muscle, with dose escalation and sequential enrollment

1 day

1 visit (in-person) on Day 01

Follow-up

Participants are monitored for safety and immunogenicity, with visits on Day 30 and telephone follow-ups from Day 09 to Day 366

12 months

1 visit (in-person) on Day 30, multiple telephone calls from Day 09 to Day 366

Long-term follow-up

Participants are monitored for adverse events and immunogenicity up to 12 months following the last study vaccination

12 months

What Are the Treatments Tested in This Trial?

Interventions

• rC19 (dose 1)
• RIV + rC19 (dose 1)
• RIV + rC19 (dose 2)
• RIV + rC19 (dose 3)
• RIV + rC19 (dose 4)

Trial Overview The study tests a combination vaccine of recombinant influenza (RIV) and different levels of adjuvanted recombinant COVID-19 (rC19) vaccines against RIV alone, rC19 alone, and placebo. Participants will receive two injections on Day 1 and follow-ups over approximately one year.

How Is the Trial Designed?

Group I: Group 7: RIV + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

Group II: Group 6: RIV + rC19 (dose 3) (in right or left deltoid) and placebo Experimental Treatment 2 Interventions

two IM injections on D01

Group III: Group 5: RIV + rC19 (dose 2) (in right or left deltoid) and placebo Experimental Treatment 2 Interventions

two IM injections on D01

Group IV: Group 4: RIV + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

Group V: Group 3: RIV (in right or left deltoid) and rC19 (dose 1) (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

Group VI: Group 2: rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

Group VII: Group 1: RIV (in right or left deltoid) and placebo (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

rC19 (dose 1) is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Nuvaxovid for:

• Prevention of COVID-19

Approved in United States as Nuvaxovid for:

• Prevention of COVID-19

Approved in Canada as Nuvaxovid for:

• Prevention of COVID-19

Approved in Japan as Nuvaxovid for:

• Prevention of COVID-19

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

The NVX-CoV2373 vaccine, evaluated in over 31,000 participants across five clinical studies, demonstrated high efficacy against COVID-19 and a well-tolerated safety profile, with common side effects including injection site pain and fatigue.

A booster dose administered six months after the initial two doses significantly increased antibody levels against COVID-19 variants, reinforcing the vaccine's effectiveness and supporting its use in both primary and booster vaccination regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Novavax COVID-19 Vaccine (NVX-CoV2373), a recombinant spike protein vaccine with Matrix-M adjuvant to prevent disease caused by SARS-CoV-2 viruses. Wilkinson, B., Patel, KS., Smith, K., et al.[2023]

The NVX-CoV2373 COVID-19 vaccine demonstrated high efficacy rates of 89.7-90.4% in clinical trials, indicating it is effective in preventing COVID-19 in adults aged 18 and older.

The vaccine has an acceptable safety profile, with most adverse reactions being mild to moderate, and serious adverse events occurring at similar low rates in both NVX-CoV2373 and placebo groups, suggesting it is safe for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. Smith, K., Hegazy, K., Cai, MR., et al.[2023]

In a study of 160 healthcare workers, the NVX-CoV2373 vaccine as a second booster resulted in significantly lower antibody responses against SARS-CoV-2 variants compared to mRNA vaccines.

Participants receiving NVX-CoV2373 experienced a higher rate of new SARS-CoV-2 infections but reported fewer adverse events, suggesting a trade-off between safety and immunogenicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of heterologous booster with protein-based COVID-19 vaccine (NVX-CoV2373) in healthy adults: A comparative analysis with mRNA vaccines. Sheng, WH., Lin, PH., Cheng, YC., et al.[2023]

OVX836, a recombinant influenza vaccine, demonstrated a favorable safety profile up to a dose of 480 μg, with mild local and systemic reactions, indicating it is well tolerated by healthy adults.

The vaccine elicited significant dose-dependent immune responses, including increased nucleoprotein-specific CD4 and CD8 T-cell responses, suggesting it may provide effective protection against influenza A and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity, safety, and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: a randomised, double-blind, placebo-controlled, phase 2a trial. Leroux-Roels, I., Willems, P., Waerlop, G., et al.[2023]

A fourth dose of the NVX-CoV2373 vaccine significantly increased antibody levels against both the ancestral SARS-CoV-2 strain and the Omicron BA.5 variant, demonstrating enhanced immunogenicity without increasing side effects.

In a study involving 1283 participants, the incidence of adverse events after the fourth dose was low (9%), and none were severe, suggesting that the vaccine remains safe even with additional booster doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a fourth homologous dose of NVX-CoV2373. Alves, K., Plested, JS., Galbiati, S., et al.[2023]

The Nuvaxovid™ vaccine, which uses a recombinant spike protein nanoparticle combined with the Matrix-M adjuvant, has been authorized for use in the EU and Great Britain, highlighting its safety and efficacy in generating immune responses against SARS-CoV-2.

This vaccine is notable for its stability, with a shelf life of 9 months at standard refrigeration temperatures, making it easier to distribute and store compared to some other COVID-19 vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: First Approval of the Protein-Based Adjuvanted Nuvaxovid (NVX-CoV2373) Novavax Vaccine for SARS-CoV-2 Could Increase Vaccine Uptake and Provide Immune Protection from Viral Variants. Parums, DV.[2022]

In a phase 3 trial with 15,187 participants, the NVX-CoV2373 vaccine demonstrated an impressive efficacy of 89.7% in preventing SARS-CoV-2 infections, with no hospitalizations or deaths reported in the vaccinated group.

The vaccine showed high efficacy against the B.1.1.7 (alpha) variant at 86.3% and an even higher efficacy of 96.4% against non-B.1.1.7 variants, while side effects were generally mild and similar to those in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. Heath, PT., Galiza, EP., Baxter, DN., et al.[2023]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06695130

NCT06695130 | Study of a Combination Vaccine ... The purpose of the study is to assess the safety and immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinant COVID-19 vaccine (rC19) ...

2. ir.novavax.com ir.novavax.com/press-releases/2025-06-11-Novavaxs-COVID-19-Influenza-Combination-and-Stand-alone-Influenza-Vaccine-Candidates-Showed-Robust-Immune-Responses-and-Were-Well-Tolerated-in-Initial-Cohort-of-a-Phase-3-Trial

Novavax's COVID-19-Influenza Combination and Stand- ... Both stand-alone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline).

3. withpower.com withpower.com/trial/combination-vaccine-for-covid-19-and-flu-be3ee

Combination Vaccine for COVID-19 and Flu The Novavax COVID-19 vaccine, known as Nuvaxovid, has shown high effectiveness rates of 89.7-90.4% in preventing COVID-19 and has been found to boost immune ...

4. sanofi.com sanofi.com/en/media-room/press-releases/2024/2024-12-11-06-00-00-2995072

Press Release: Two combination vaccine candidates for ... Both Fluzone High-Dose and Flublok have been proven to prevent more influenza infections in older adults than standard-dose influenza vaccines ...

5. gavi.org gavi.org/vaccineswork/dual-covid-19flu-shot-more-effective-individual-vaccines

Study suggest dual COVID-19/flu shot is more effective ... A combined mRNA vaccine against COVID-19 and seasonal influenza appears to trigger stronger immune responses against both viruses compared to ...

6. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-and-Patient-Package-Insert-NUVAXOVID.pdf

Package Insert and Patient Package Insert - NUVAXOVID COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). 76. Safety data accrued in Studies 1, 5, 6, and 7 are relevant to NUVAXOVID because the vaccines. 77.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031483/

Innovations, Challenges, and Future Prospects for ... For example, COVID-19 and influenza combination vaccines demonstrated good tolerance and immunogenicity, with dose adjustments resolving antigen ...