Who can participate?
Healthy children at least 12 years old and adults who intend to receive a Pfizer or Moderna COVID-19 vaccine and the annual flu vaccine and either:
- Have not received any COVID-19 vaccine or
- Are at least 18 years old and received both doses of the Pfizer or Moderna COVID-19 vaccine with the second dose at least 6 months ago and would like a COVID-19 booster
What will happen in the study?
There are at least six study visits over about 4 months. Here are some of the things that will happen in this study:
You as an adult participant, or your child will:
- Answer questions about your or your child’s health, current medications, demographics and your or your child’s flu and COVID-19 vaccination history.
- Have vital signs taken.
- Be asked about your or your child’s quality of life.
- Have blood samples drawn.
- Be randomly (like flipping a coin) assigned to receive either the flu vaccine or a placebo with a Pfizer or Moderna COVID-19 vaccine.
- Receive a Pfizer or Moderna COVID-19 vaccine.
- Receive either a flu vaccine or a placebo at the first visit, then return two weeks later. Those given a placebo at the first visit will get the flu vaccine. Those given a flu vaccine will get a placebo at the second visit.
- Receive the second COVID-19 vaccine if getting the first dose in the study.
- Complete an online or paper symptom diary daily for seven days after each vaccine dose and Quality of Life assessment daily for seven days after the first vaccine dose.
- Be assessed for any immediate symptoms after vaccination.
- Return for an unscheduled visit, if needed, to assess an adverse reaction to the vaccine(s).
You will be given a consent form that explains all the details of the study. A member of the study staff will review the consent form with you and answer all your questions before you agree to be in the study or allow your child to be in the study.
What are the good things that can happen from this research?
If you agree to take part in this study, there may be direct medical benefits to you or your child. You or your child will receive the recommended flu and COVID-19 vaccinations. The flu and COVID-19 vaccines have been shown to prevent flu and COVID-19 infection. As with any licensed vaccine, protection may not occur in 100% of vaccinated persons. However, you or your child may develop protective antibodies against the flu and COVID-19.
Also, information learned from this study may help researchers understand if the flu and mRNA COVID-19 vaccines are safe to be given on the same day.