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.
Learn more about Pfizer and BioNTech’s clinical trial for a COVID-19 and flu vaccine using mRNA technology.
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 a combination COVID-19 and flu vaccine compared to receiving a COVID-19 or flu vaccine alone.
Who may participate
Joining a clinical trial is an important and personal decision. We thank you for considering participation.
This clinical trial is enrolling healthy adults who:
- Are 18 years of age or older
- 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 requirements for taking part in this clinical trial. The study team will explain these to you if you’d like to learn more.
Age
18+ years
Medical and vaccination history
Generally healthy and have not received a COVID-19 or flu vaccine in the last 5 months
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
Get started — See if you may be eligible
Answer a 2-minute questionnaire.
A first step as you consider this study is to answer a 2-minute online questionnaire about your health and medical history. You will also be asked to provide your zip code, which may be used by Pfizer, and our partners working on this study to help improve the study recruitment process. If your answers show the study might be a good fit for you, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator.
Speak with a study representative.
If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your medical history to see if you may be able to participate and be referred to a study clinic that you select.
Confirm your eligibility.
Your answers to these questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
What to expect
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 vaccine groups. This clinical trial does not include a placebo (an injection with no active ingredient).
- Group 1: Investigational COVID-19 vaccine
- Group 2: Investigational flu vaccine
- Group 3: Combination investigational flu and investigational COVID-19 vaccine
- Group 4: Combination investigational flu vaccine and licensed COVID-19 vaccine
- Group 5: Licensed COVID-19 vaccine
- Group 6: Licensed flu vaccine
You will receive your study vaccine at your first study visit. Initially, neither you nor your study doctor will know which vaccine you have received. After one month, you may be told which vaccine you received so you can get a licensed flu or COVID-19 vaccine, if desired.
Length of study
6 months
Number of study visits
At least 4 visits
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.
mRNA vaccines work by telling your body to produce proteins that look just like certain parts of the virus. The immune system reacts to these proteins in a similar way to a real virus. As a result, certain immune system cells “remember” how to recognize these proteins quickly and fight the real infection if it happens in the future.
Your participation matters
Your participation matters
Frequently asked questions
Will I know which vaccine I am receiving?
No, neither you nor the study doctor will know which vaccine you have received. The person giving the injections will know but will not be able to talk about it with you.
Is there a cost to participate?
The study vaccine and study-related procedures will be provided at no cost. You will also be compensated for completing study-related activities.
What if I change my mind?
Participating in a clinical trial is completely voluntary (your choice). You can choose to leave the study at any time, for any reason, without penalty to you. If you decide not to participate, your future medical care will not be affected.
Can I receive other COVID-19 and/or seasonal flu vaccines while participating in this clinical trial?
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 the one-month follow-up visit. After your one-month follow-up visit, you may be told which vaccine you received so you can get a licensed flu or COVID-19 vaccine, if desired. Participants interested in receiving seasonal flu and/or COVID-19 vaccines during the study should discuss this with the study doctor.
What are the possible side effects?
As with any vaccine, local reactions at the injection site can be common – such as redness, swelling, or pain. There is also potential for other symptoms like a mild fever or fatigue. The known side effects will be further explained in the Informed Consent Document (ICD) and discussed with you by the study doctor before you join the clinical trial. If we learn any new information about the study vaccine during the clinical trial, the study doctor will share that with you as well.
What kinds of tests and procedures will be performed?
At the beginning of the clinical trial, the study doctor will ask you about your medical history including previous vaccinations and any medications you are currently taking. You will be given an electronic diary to complete daily for one week after your vaccines so the study team can monitor your health. You will also have your blood drawn up to 4 times during the 6 months you are in the clinical trial. The study team will give you more information about the tests and procedures during the review of the Informed Consent Document (ICD).
