One and done

Learn more about Pfizer and BioNTech’s clinical trial for an investigational COVID-19 and flu vaccine using mRNA technology

Learn more about Pfizer and BioNTech’s clinical trial for an investigational COVID-19 and flu vaccine using mRNA technology

About this clinical trial

Who can take part?

This clinical trial may be an option if you:

  • Are [18/65] years of age or older*
  • Are generally healthy with no major changes in your recent medical history
  • Have not received a flu or COVID-19 vaccine in the last [5] months
    (including investigational or licensed)
  • 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.

[*This clinical trial will enroll ages 18-64 and 65+ at different times. If you are interested in participating, please contact the study team to confirm if your age group is currently enrolling.]

Study duration

You will be in the clinical trial for about [6 months].

Study visits

You will have at least [4] study visits.

Study-related costs

The study vaccines and study-related procedures will be provided at no cost. You will also be compensated for completing study-related activities.

About the study vaccines

The mRNA-based vaccines being studied are a combination of Pfizer and BioNTech’s updated investigational COVID-19 vaccine and an investigational flu vaccine being developed by Pfizer. If this clinical trial is a good fit for you and you agree to participate, you will be randomly assigned (like rolling dice) to receive an injection from one of the following study vaccine groups. This clinical trial does not include a placebo (an injection with no active ingredient).

Groups
Single injection
1
Investigational COVID-19 vaccine
2
Investigational flu vaccine
3
Combination investigational flu and investigational COVID-19 vaccine
4
Combination investigational flu vaccine and licensed COVID-19 vaccine
5
Licensed COVID-19 vaccine
6
Licensed flu vaccine
The study team will explain more about the vaccine groups. Neither you nor your study doctor will know which vaccine you have received.

What else to know

 

  • 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.
  • Safety is always the top priority of any clinical trial. Your health will be carefully monitored throughout the clinical trial by the study team.
  • If you take part in this clinical trial, it is important that you do not receive other seasonal flu and/or COVID-19 vaccines until you have completed your one-month follow-up visit. If you wish to receive a licensed COVID-19 or flu vaccine after this visit, you may be told which study vaccine you received.

Volunteering is your choice. You can choose to leave the clinical trial at any time, for any reason.

Both COVID-19 and flu continue to be major public health concerns around the world.

COVID-19 and flu vaccination programs take place at the same time each year. Currently, two separate shots are needed to protect against both COVID-19 and flu. A single shot could make it easier and more convenient for people to be protected against both viruses.

This clinical trial will help us understand how people respond to different dose levels of an investigational combination COVID-19 and flu vaccine compared to receiving a COVID-19 or flu vaccine alone.

Staying up to date on your vaccines can help protect you from serious illness. By participating in this clinical trial, you may help lower your risk of illness from COVID-19 and flu while contributing to research that could simplify annual vaccination programs globally.

Thank you for taking the time to learn more.

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?

contact our team: 786-772-0510

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