Flu and COVID-19 Vaccines for Coronavirus and Influenza

Recruiting at 29 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: 5

Duration: 1 day

2645 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the effects of flu and COVID vaccines when administered alone or combined in one shot. Participants will be divided into groups to receive either a flu vaccine, a COVID vaccine, or a combination of both (investigational influenza and COVID-19 combination vaccine). The trial seeks healthy individuals who have not received any COVID or flu shots in the last 150 days. Participants will be involved for about six months, with at least four visits to the trial site. As a Phase 1 and Phase 2 trial, this research focuses on understanding the treatment's effects and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to important 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, but you cannot have had a flu or COVID vaccine in the last 150 days or taken antiviral flu medications like Tamiflu in the last 180 days.

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

Research has shown that the new flu and COVID-19 combination vaccine is safe so far. Studies have not identified any major safety issues. Participants in these studies have tolerated the vaccine well, with no serious side effects reported.

This new vaccine is undergoing early-stage clinical trials (Phase 1 and 2), which primarily focus on safety. Safety is closely monitored and is the main goal of these studies. The absence of safety problems so far is promising, suggesting that the vaccine is generally safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the investigational influenza and COVID-19 combination vaccines because they offer a potentially convenient dual-protection approach, targeting both flu and COVID-19 with a single shot. Unlike current vaccines, which require separate doses for each virus, these combination vaccines aim to simplify the vaccination process. This could enhance vaccine uptake and improve compliance, ensuring broader protection against both viruses simultaneously. Additionally, the study explores multiple dosage levels to optimize effectiveness and safety, potentially paving the way for more personalized vaccination strategies.

What evidence suggests that this trial's treatments could be effective?

Research has shown that vaccines combining flu and COVID-19 elements can trigger strong immune responses. In this trial, participants will receive different versions of these combination vaccines, which may effectively protect against both viruses. For example, some studies found that recipients of these combined vaccines developed strong immunity to both flu and COVID-19. Early results suggest they are safe, with most side effects being mild and similar to those of regular vaccines. The goal is for one shot to provide protection against both viruses, making it easier and more convenient. ^{2 4 5 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Healthy individuals aged 18 or older are eligible for this study, which involves receiving a single shot of either a flu or COVID vaccine, alone or in combination. Participants will be involved for approximately 6 months and must visit the study site at least four times.

Inclusion Criteria

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

Exclusion Criteria

I have been vaccinated against COVID-19 within the last 150 days.

I have not had a flu vaccine in the last 150 days.

I haven't taken flu antivirals like Tamiflu in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one shot of 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 receiving the vaccine

6 months

At least 4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Investigational Influenza and COVID-19 Combination Vaccine

Trial Overview

The trial is testing how different vaccines (flu and COVID-19) work when given separately or together. This includes licensed influenza vaccines, an approved COVID-19 vaccine, as well as investigational flu and COVID-19 vaccines.

How Is the Trial Designed?

Group I: Arm QQ Experimental Treatment 1 Intervention

High Dose Investigational Influenza Vaccine (2)

Group II: Arm PP Experimental Treatment 1 Intervention

Medium Dose Investigational Influenza Vaccine (1)

Group III: Arm OO Experimental Treatment 2 Interventions

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)

Group IV: Arm NN Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)

Group V: Arm MM Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)

Group VI: Arm LL Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)

Group VII: Arm L Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)

Group VIII: Arm KK Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)

Group IX: Arm K Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)

Group X: Arm JJ Experimental Treatment 2 Interventions

Low Dose COVID-19 Vaccine ( 1c)

Group XI: Arm J Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)

Group XII: Arm II Experimental Treatment 1 Intervention

Low Dose COVID-19 Vaccine ( 1b)

Group XIII: Arm G Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)

Group XIV: Arm F Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)

Group XV: Arm EE Experimental Treatment 2 Interventions

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)

Group XVI: Arm E Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)

Group XVII: Arm DD Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)

Group XVIII: Arm D Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)

Group XIX: Arm CC Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)

Group XX: Arm C Experimental Treatment 1 Intervention

Low Dose COVID-19 Vaccine ( 1c)

Group XXI: Arm BB Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)

Group XXII: Arm B Experimental Treatment 1 Intervention

Low Dose COVID-19 Vaccine ( 1b)

Group XXIII: Arm AA Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)

Group XXIV: Arm A Experimental Treatment 1 Intervention

Low Dose COVID-19 Vaccine (1a)

Group XXV: Arm H Active Control 1 Intervention

Licensed COVID-19 Vaccine

Group XXVI: Arm I Active Control 1 Intervention

Licensed Influenza Vaccine (1)

Group XXVII: Arm SS Active Control 2 Interventions

Licensed Influenza Vaccine (3)

Group XXVIII: Arm GG Active Control 2 Interventions

Licensed Influenza Vaccine (3)

Group XXIX: Arm RR Active Control 2 Interventions

Licensed COVID-19 Vaccine

Group XXX: Arm FF Active Control 2 Interventions

Licensed COVID-19 Vaccine

Group XXXI: Arm HH Active Control 2 Interventions

Licensed Influenza Vaccine (2)

Group XXXII: Arm M Active Control 1 Intervention

Licensed COVID-19 Vaccine

Group XXXIII: Arm N Active Control 1 Intervention

Licensed Influenza Vaccine (2)

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

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMsa2514268

Updated Evidence for Covid-19, RSV, and Influenza ...

We reported outcomes for four domains: epidemiology, vaccine efficacy or effectiveness, safety, and coadministration. Epidemiologic data were ...

2.

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 ...

Participants who received a licensed influenza and COVID-19 vaccine with co-administration continued to elicit robust immune responses against ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12103547/

Comparing Moderna's mRNA-1083 and Pfizer's dual-target ...

This review examines Moderna's mRNA-1083 and Pfizer/BioNTech's mRNA-1020/1030 dual-target vaccines for COVID-19 and influenza.

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.

ir.novavax.com

ir.novavax.com/press-releases/2023-05-09-Positive-Phase-2-Topline-Results-Show-Novavaxs-COVID-Influenza-Combination%2C-Stand-alone-Influenza-and-High-dose-COVID-Vaccine-Candidates-Demonstrate-Robust-Immune-Responses

Positive Phase 2 Topline Results Show Novavax's COVID ...

All three vaccine candidates contained Novavax's patented Matrix-M adjuvant and showed reassuring preliminary safety profiles and reactogenicity.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06683352

NCT06683352 | A Study to Learn About Flu and COVID-19 ...

This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40332892/

Immunogenicity and Safety of Influenza and COVID-19 ...

Objective: To assess the immunogenicity and safety of an investigational mRNA-1083 vaccine against seasonal influenza and SARS-CoV-2 in adults ...