Help make dual protection against COVID-19 and flu possible with a combination vaccine
Learn more about Pfizer and BioNTech’s clinical trial for a COVID-19 and flu combination vaccine using mRNA technology.
About this clinical trial
Who can take part?
This clinical trial may be an option if you:
• Are [at least 18 years old / 18 to 64 years old / at least 65 years old]
• Are generally healthy with no major changes in your recent medical history
• Have not received a flu or COVID-19 vaccine for the 2024-2025 season (generally given after August 2024)
• Have not tested positive for flu in the last 6 months
• Do not have a history of severe allergic reactions associated with any vaccine
There are other study requirements that the study team will discuss with you.
Study duration
You will be in the clinical trial for about [six months]
Study visits
You will have at least three study visits
Study-related costs
The study vaccines and study-related procedures will be provided at no cost. You will also be reimbursed for each study visit completed.
About the study vaccines
The vaccines being studied are a combination of Pfizer and BioNTech’s updated COVID-19 vaccine and an investigational mRNA-based flu vaccine being developed by Pfizer.
Participants will be randomly assigned (like rolling dice) to one of the following groups:
| Group 1 | Investigational mRNA flu vaccine | + | Placebo |
| Group 2 | Licensed or investigational mRNA COVID-19 vaccine | + | Placebo |
| Group 3 | Investigational flu and COVID-19 combination vaccine | + | Placebo |
| Group 4 | Licensed flu vaccine | + | Licensed COVID-19 vaccine |
The study team will explain more about the vaccine options. Neither you nor your study doctor will know which of these vaccines you have received.
What else to know
• You will receive your study vaccines at your first study visit. Some participants will also receive a placebo injection. The placebo looks like the study vaccines, but it does not
contain any active ingredients.
• You may be told which vaccine(s) you received after your one-month follow-up visit if you wish to receive a licensed flu or COVID-19 vaccine.
• Before you join the clinical trial, you will be given all of the details about participation, including potential benefits and risks. If you would like to participate, you will provide
your written consent (permission) before joining the clinical trial.
• Your health will be carefully monitored throughout the clinical trial by the study team.
Volunteering is your choice. You are free to stop being in the study at any time, for any reason.
Both COVID-19 and flu continue to be major public health concerns around the world.
Because infections tend to peak in the winter months, vaccination programs for COVID-19 and flu are likely to occur at the same time each year. A combination vaccine will make it easier and more convenient to get protection against both infections with just one shot.
This clinical trial will help us understand how people respond to different dose levels of a combination vaccine compared to receiving a flu or COVID-19 vaccine alone.
Tomorrow’s breakthroughs start today with you
Participation by people of all backgrounds is critical to developing vaccines that protect against infectious diseases [like COVID-19 and flu]. The greater the diversity among clinical trial participants, the more we can learn about potential vaccines and how they work for different people, including those most at-risk because of their age, race, ethnicity, or where and how they live. Each new vaccine breakthrough helps us reach more people to prevent and reduce the spread of disease.
Ready to learn more?
You may also contact our team: 786-772-0510
