As new COVID-19 variants continue to emerge, getting vaccinated can help protect your child from serious illness. If you are thinking about vaccinating your child against COVID-19 for the first time, consider joining our ongoing vaccine clinical trial.
Though most children aren’t seriously harmed by COVID-19, some do become very sick. The CDC recommends that children receive an updated COVID-19 vaccine for better protection against newer variants.
This study will help us learn how well one dose of Pfizer-BioNTech’s updated COVID-19 vaccine works in children who have not been previously vaccinated. The study vaccine has been authorized by the United States Food and Drug Administration for children at least 6 months of age. It is designed to protect against one of the newer COVID-19 variants called XBB.1.5.
Who may participate
Joining a clinical trial is an important and personal decision. We thank you for considering participation as an option that may be right for your family.
This study is enrolling children who:
- Are 5 to 11 years old
- Are generally healthy
- Have not been vaccinated for COVID-19
Age
5 – 11 Years
Current vaccination status
No prior vaccines for COVID-19
Each clinical trial has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if your child qualifies for the study.
Get started – See if your child 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 child’s health and medical history. If your answers show the study might be a good fit for your child, 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 child’s medical history to see if they may be able to participate and be referred to a study clinic that you select.
Confirm your child’s eligibility.
Your answers to these questions will only be linked to you if your responses indicate that your child 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 or your child. Only the study staff can determine if your child meets the study’s eligibility criteria and is able to enroll in the study.
What to expect
If your child enrolls in the study, they will receive a single dose of the study vaccine at their first study visit.
Your child’s health will be carefully monitored by the study team for six months following their vaccination. They will have a follow-up visit at the study clinic about one month after they receive the study vaccine. The study team will also contact you by telephone six months after their vaccination.
There is no cost to participate in this study. You will also be compensated for completing study-related activities.
Number of vaccine doses
One dose
Study visit schedule
At least two clinic visits and one telephone call over six months
Help make a difference
Children under the age of 10 account for 47% of pediatric COVID-19 deaths worldwide.1 Rates of severe disease and hospitalizations vary greatly by age, race and ethnicity, family income levels, and location.1,2,3 That is why it is important that children of all backgrounds participate in this study – to reflect the diversity of families around the world looking for better protection against COVID-19.
References:
1. Child Mortality and COVID-19. UNICEF. Updated March 2023. Accessed September 28, 2023.
https://data.unicef.org/topic/child-survival/covid-19/
2. Children and COVID-19: State-Level Data Report. American Academy of Pediatrics. Updated May 15, 2023. Accessed September 28, 2023.
https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/
3. Obe A, et al. The Impact of the COVID-19 Pandemic on Black Children: A Two-Year Assessment. Black Coalition Against COVID. March 2023. Accessed November 6, 2023.
https://blackcoalitionagainstcovid.org/wp-content/uploads/2023/03/BCAC_Report.pdf
Help make a difference
Frequently asked questions
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 and discussed with you by the study doctor before you consider having your child join the study. If there is any new information that we learn about the study vaccine during the clinical trial, the study doctor will share that with you as well.
