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This is a research study that will compare how well two different FDA-approved flu vaccines protect people against the flu. Your participation may provide helpful information about whether one of the two study vaccines provides better protection against the flu and about how we study flu vaccines in the future.

You will answer questions about your current and past medical conditions and flu vaccines you had in the past 5 years. Next, you will be assigned to receive one licensed flu vaccine from the study team. Licensed flu vaccines have been approved by the Food and Drug Administration for safe use in humans and are regularly given to people in the United States each year. After you receive the flu vaccine, we will ask you to respond to weekly text messages or emails about whether you feel sick with flu symptoms. During flu season, if you have flu symptoms, we will ask you to complete additional short surveys about how you feel. We will also ask you to collect a nasal swab one time during each illness. You will either ship or drop off your nasal swab at a central location.

Your nasal swab samples will be sent to a laboratory to find out if you have been infected with flu. Your samples may also be tested for other diseases that cause symptoms like cough and runny nose. Because COVID-19 is a public health emergency, your samples will also be tested for COVID-19. Your COVID-19 test result and your personal identifiable information such as your name, telephone number, age, and gender will be shared with the local health department or your school as required by local, state or federal communicable disease reporting laws.

At the end of the study, we will ask you to complete a short survey about whether you received other vaccines while taking part in the study.

The Centers for Disease Control and Prevention (CDC) is sponsoring this study. Westat, a research company based in Rockville, Maryland is managing the study and collecting information from you.

This study will include up to around 14,600 people who are 18-64 years old. This study will take place in multiple places across the country.

Influenza, or flu, is an illness that spreads around the world, including the United States, each year. Anyone can get the flu. Flu can cause cough, fever, chills, sore throat, muscle aches, tiredness, headache, and runny or stuffy nose. In the United States each year, thousands of people die from the flu and many more are hospitalized. Although older adults and people with certain health conditions have a higher risk of getting seriously sick from the flu, previously healthy adults can also become very ill.

The study begins the day you enroll until the flu season has ended in your community or through May 2023, whichever comes first.

No, taking part in this study is voluntary. This means you can choose if you want to be in the study or not. You may decide not to participate or to stop participating at any time, for any reason.

Deciding not to participate or to stop participating will not result in any penalties.

No, only one person per household may participate in the study.

• You will answer a short questionnaire to see if you are eligible to participate.
• If you are eligible, you will answer questions about your current and past medical conditions and flu vaccines you had in the past 5 years.
• You will schedule a visit with your local participating organization to receive an FDA-approved flu vaccine.
• Right before you go to your scheduled visit, we will ask you a few questions to make sure you are well to receive the flu vaccine. If you are not well, you will need to reschedule your appointment.

• If you did not answer the questions to make sure you are well to receive the flu vaccine before your visit, we will ask them at the start of your visit. If you are not well, you will need to come back when you feel better.
• A study health care professional will inject one dose (0.5mL) of study flu vaccine in the muscle of your upper arm.
• You will learn how to swab your nose to collect samples for flu and COVID-19 testing. We will give you supplies to swab your nose at home if you have flu symptoms during flu season. We will also give you shipping and/or packaging materials to send the swabs to the study laboratory or to the local drop-off location.
• You will choose which day of the week you would like to receive a text message from the study staff asking whether you have had flu symptoms during the past week.
• After you are vaccinated, you will be given a document with proof of your flu vaccination in case you need this proof for work or school.

Text messaging and email communication before and during flu season. You will be asked to answer a few questions by text message or email once a week about whether you have recently gotten a fever, cough, sore throat, or runny nose. We will also ask about mask use if you have flu-like symptoms.

Once study staff determine that flu season has started or by the first week of December, you will also be asked to send a text to the study team if you develop flu symptoms in between the weekly text messages or emails. If you tell us that you have recently had flu symptoms, we will send you daily links to a short web survey about your illness. We will ask you to complete the surveys for up to 14 days.

Swabbing and shipping/drop-off during flu season. Once study staff determine that flu season has started or by the first week of December, we will ask you to collect a nasal swab each time you develop fever, cough, sore throat, or runny nose. Each time you collect a nasal swab, you will either ship or drop it off at a central location. This should be done as soon as possible, ideally within 5 days of collecting the swab. The swab will be tested for flu and COVID-19 and possibly other diseases that cause symptoms like coughing or runny nose.

End of study. At the end of the study, we will ask you to complete a few questions about whether you received other vaccines during this time.

Participants will receive one of two U.S. FDA-approved and licensed vaccines as part of this study, either a newer flu vaccine, called a recombinant (new gene combination) vaccine or a standard egg-based flu vaccine.

All study vaccines are licensed for use in adults 18 years or older in the United States. At your vaccine appointment a computer program will decide which vaccine you will get. This will be done by a random process that is like pulling a name out of a hat. No one chooses which vaccine you get. We will not know which vaccine you are getting, and neither will you. Only the study staff that are licensed to give vaccines at this study site will know which vaccine you get. You have a 50/50 chance of receiving either a newer flu vaccine, called a recombinant (new gene combination) vaccine or a standard egg-based flu vaccine.

Yes, the study staff where you receive your flu vaccination can provide you with a notice for your employer/school.

Your nasal swab samples will be sent to a lab to find out if you have been infected with flu. Because COVID-19 is a public health emergency, your samples will also be tested for COVID-19. Your samples may also be tested for other diseases that cause symptoms like cough and runny nose.

If there are leftover samples that are not used for this study, we are also asking your permission to store them for future testing for other diseases like flu. We will remove all information that could be used to identify you, such as name, birthdate, and address, before your samples are used for future studies. Samples may be stored at CDC or a CDC-chosen storage facility and may be tested by CDC or other CDC-chosen investigators. Samples may also be shared with other research groups to test for other diseases like flu.

All flu testing will be done for study purposes only; we will not share flu test results with you during the study. If you test positive for flu during the study, we may contact you at the end of the study to see if you would like to participate in a follow up study of those people who had flu during the flu season.

If any of your nasal swabs are positive for COVID-19, we will share the positive result with you. We will not share negative COVID-19 results with you. COVID-19 results will be reported to the local health department as required by local, state or federal communicable disease reporting laws.

COVID-19 results from your sample may not be available right away. These results are part of this research study and are not medical results. Follow up with a medical provider if you want to be tested for any health problem or have questions about your health or whether you should stay home and/or separate yourself from others.

If you feel sick at any time during the study, you should consult with your medical provider as you normally would for illness symptoms. Although we will share positive COVID-19 test results with you, the results will not be available until a week or more after you drop off or ship your nasal swab. Although the tests for COVID-19 used in this study are very accurate, they are not perfect. It is unlikely, but a negative test result can happen even if you are infected.

You will get a flu vaccine that may protect you against flu infection during the 2022-23 flu season. Your participation may also provide helpful information about whether newer vaccines provide better protection than traditional vaccines against the flu.

There is no cost to you to receive a flu vaccine as part of this study. Standard message and data rates will apply for receiving and sending study text messages. We will pay for shipping nasal swab samples to the lab, but you will be responsible for bringing your samples to a central/shipping location (including travel time or costs).

Yes, to thank you for your time and effort, we will provide you up to $195 in gift cards, depending on the number of study activities you complete:

We will ask you to respond to study questions weekly on a day you will choose during the vaccine visit. Please respond to the study questions on your selected schedule. If you miss a day, please respond within the next day or two.

You will collect a nasal swab during flu season if you develop fever, cough, sore throat, or runny/stuffy nose. You will only need to collect a nasal swab one time per illness.

You will follow the instructions given to you with your swab kit. These instructions will tell you how to pack the swab and where to send it or drop it off.

If you are too sick to drop off or ship the swab, you should keep it in the refrigerator until you can drop it off or ship it. If you have questions, you may contact the help desk via email at RAIVENSupport@westat.com or call 1-855-516-1745.

If you have questions, problems, or need another nasal swab kit, please contact the study using the local contact information provided when you receive your collection kit. You may also send an email to RAIVENSupport@westat.com.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that put safeguards in place to protect the privacy of patient’s health information, known as protected health information or PHI, from being shared without the patient’s consent or knowledge. HIPAA gives patients control over who their information is shared with and for what purpose.

You have given us the authorization (i.e., your permission) to use your protected health information and any other information collected during the research study that can identify you. The health information that we may collect and use for this research includes information about past or current medical conditions or treatments.

The authorization or permission that you gave also allows the study researchers to look at your personal health information collected as part of this study and share it with our research partners (Westat, CDC, and participating study partners) for lab testing and data analysis. In addition, study researchers may share your personal health information collected as part of this study with review boards and other persons who watch over the safety, effectiveness, and conduct of research such as authorized persons from the Office of Human Research Protections ("OHRP").

We will not share any information that could identify you, such as your name or contact information. The CDC may keep the de-identified research records indefinitely. Your authorization to use and share your health information does not have an expiration (ending) date.

You may change your mind and revoke (take back) this consent and authorization at any time and for any reason. To revoke consent, you must write to Dr. Sarah Ball, the project director in charge of the study, at the study email: RAIVENSupport@Westat.com. If you revoke your consent and authorization, you will not be allowed to continue taking part in this research and no additional information about you will be collected fort his study. Even if you revoke your consent and authorization, the study researchers may still use and share information already collected from you for this research study.

We asked for your permission to check your medical records to confirm what kind of flu vaccine and how much of the flu vaccine you received in the past. These details may come from medical records from your health care provider or pharmacy, or from state and/or city vaccine registries. You could choose not to give permission to confirm your flu vaccine history and still participate in the study.

Your samples will be tested for flu and COVID-19 at a certified testing laboratory. Your COVID-19 test result and your personal identifiable information such as your name, telephone number, age, and gender will be shared with the local health department as required by local, state or federal communicable disease reporting laws. Other than required reporting of COVID-19 results, we will only share information that you give us for the study with other study researchers for the purposes of this study. The study staff will handle your personal information in a confidential manner. The personal information about you that is used in this study will be coded so that no one can directly identify you.

Your personal health information is information about you that could be used to find out who you are. However, the study staff will safeguard your personal information by following Federal privacy rules that are intended to reduce any chance of personal identification.

This research study has a Certificate of Confidentiality from the Centers for Disease Control and Prevention (CDC). Unless you say it is okay, study staff cannot release information that may identify you for a legal action, a lawsuit, or as evidence. This protection applies to requests from federal, state, or local civil, criminal, administrative, legislative, or other proceedings.

Participants in this year’s study (2022-23) may be able to participate again next year (2023-24). We may contact you to participate in the second year, which will start in the fall of 2023. The second year will involve the same activities like answering questions by text message or email and taking nasal swabs. It will also include getting a flu vaccine. You do not have to participate in this future study.

If you have questions about the study, please contact the study help line at 1-855-516-1745 or via email at RAIVENsupport@westat.com. The help desk phone number is covered Monday through Friday from 9:00 am to 10:00pm ET, and weekends from 2:00 pm – 8:00 pm ET.

The Westat Institutional Review Board (IRB) has approved this study. If you have questions about your rights and welfare as a research participant or for a research related injury, please call the Westat Human Subjects Protections office at 1-888-920-7631. Please leave a message with your first name, the name of the research study (RAIVEN) that you are calling about, and a phone number beginning with the area code. Someone will return your call as soon as possible.