Flu and COVID-19 Vaccines for Virus Protection

Recruiting at 21 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioNTech SE

Must not be taking: Antivirals

Disqualifiers: Recent flu or COVID vaccine

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

1353 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 times.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have been treated with antiviral therapies for influenza, you must not have taken them within 180 days before starting the trial.

What data supports the effectiveness of the COVID-19 Vaccine, GEO-CM04S1, and related treatments?

The research indicates that vaccines targeting the spike protein of SARS-CoV-2, like the ones mentioned, have been effective in generating neutralizing antibodies and preventing severe disease. Despite challenges with new variants, these vaccines have shown significant efficacy in reducing COVID-19-related infections and mortality. ^{1 2 3 4 5}

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

Studies have shown that administering flu and COVID-19 vaccines together is generally safe, with side effects similar to those of each vaccine given separately. Most reported side effects are mild or moderate, and public health authorities support co-administration. ^{6 7 8 9 10}

How is the Flu and COVID-19 Vaccines for Virus Protection treatment different from other treatments?

This treatment is unique because it combines vaccines for both influenza and COVID-19, potentially increasing vaccination uptake and providing protection against both viruses with a single administration. It leverages existing influenza vaccine infrastructure to create a cost-effective and scalable solution, which may simplify the vaccination process and reduce the burden of receiving multiple separate vaccines. ^{8 11 12 13 14}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Healthy individuals aged 18 or older are eligible for this study, which examines responses to flu and COVID-19 vaccines. Participants will receive shots in both arms and must commit to at least three visits over six months.

Inclusion Criteria

Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.

I am 18 years old or older.

Exclusion Criteria

I have taken antiviral medication for the flu in the last 6 months.

I have received a flu or COVID-19 vaccine for the 2024-2025 season.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one shot in each arm, either a flu or COVID vaccine, alone or mixed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

At least 3 visits (in-person)

Treatment Details

Interventions

• COVID-19 Vaccine
• Influenza and COVID Combination Vaccine
• Investigational Influenza Vaccine
• Licensed Influenza Vaccine 1
• Licensed Influenza Vaccine 2

Trial Overview The trial is testing how people respond to different combinations of flu and COVID-19 vaccines. This includes licensed influenza vaccines, an investigational influenza vaccine, a combination vaccine, a standalone COVID-19 vaccine, and placebos.

Participant Groups

Group I: Arm N Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 7) and Placebo

Group II: Arm M Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 6) and Placebo

Group III: Arm L Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 5) and Placebo

Group IV: Arm K Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 4) and Placebo

Group V: Arm J Experimental Treatment 2 Interventions

Investigational Influenza Vaccine (Dose 3) and Placebo

Group VI: Arm I Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 3) and Placebo

Group VII: Arm H Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 2) and Placebo

Group VIII: Arm G Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 1) and Placebo

Group IX: Arm F Experimental Treatment 2 Interventions

Investigational Influenza Vaccine (Dose 2) and Placebo

Group X: Arm D Experimental Treatment 2 Interventions

Investigational Influenza Vaccine (Dose 1) and Placebo

Group XI: Arm B Experimental Treatment 2 Interventions

COVID-19 Vaccine (Dose 2) and Placebo

Group XII: Arm A Experimental Treatment 2 Interventions

COVID-19 Vaccine (Dose 1) and Placebo

Group XIII: Arm C Active Control 2 Interventions

COVID-19 Vaccine (Dose 3) and Placebo

Group XIV: Arm E Active Control 2 Interventions

Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)

Group XV: Arm EE Active Control 2 Interventions

Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Most adverse events reported from COVID-19 vaccines were mild or moderate, indicating a generally favorable safety profile during clinical trials.

However, some viral vector-based vaccines were associated with thrombotic events, highlighting the need for ongoing studies and post-marketing surveillance to fully understand potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[COVID-19 vaccine safety]. Chaparro Mérida, NA., Moreno Samper, D., Lacato, AOF.[2022]

During the first 6 months of the US COVID-19 vaccination program, over 298 million doses of mRNA vaccines were administered, with the majority of reported adverse events being mild and short-lived, indicating a favorable safety profile.

Out of 340,522 reports to the Vaccine Adverse Event Reporting System (VAERS), 92.1% were classified as non-serious, and less than 1% of participants sought medical care after vaccination, suggesting that while reactogenicity was common, it was generally manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. Rosenblum, HG., Gee, J., Liu, R., et al.[2023]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

An Overview of Vaccines against SARS-CoV-2 in the COVID-19 Pandemic Era. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

SARS-CoV-2: Emergence of New Variants and Effectiveness of Vaccines. [2022]

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

SARS-CoV-2 vaccine candidates in rapid development. [2021]

4. England pubmed.ncbi.nlm.nih.gov

COVID-19 vaccination efficacy in numbers including SARS-CoV-2 variants and age comparison: a meta-analysis of randomized clinical trials. [2022]

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

A critical overview of current progress for COVID-19: development of vaccines, antiviral drugs, and therapeutic antibodies. [2023]

6. England pubmed.ncbi.nlm.nih.gov

An observational study of adverse drug reactions to COVID-19 vaccines reported to the New Mexico poison center hotline. [2023]

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

Protocol of a scoping review of systematic reviews and meta-analyses about COVID-19 vaccines and associated adverse events from vaccination. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

COVID-19 and Seasonal Influenza Vaccination: Cross-Protection, Co-Administration, Combination Vaccines, and Hesitancy. [2022]

9. Peru pubmed.ncbi.nlm.nih.gov

[COVID-19 vaccine safety]. [2022]

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

Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. [2023]

11. China pubmed.ncbi.nlm.nih.gov

[Consideration on implementation of co-administration of Seasonal Influenza and COVID-19 vaccines during pandemic in China]. [2022]

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

Influenza Virus and SARS-CoV-2 Vaccines. [2023]

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

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

14. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a SARS-CoV-2 inactivated vaccine (CoronaVac) co-administered with an inactivated quadrivalent influenza vaccine: A randomized, open-label, controlled study in healthy adults aged 18 to 59 years in China. [2022]