With new variants continuing to emerge, getting vaccinated can help protect your little one 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.
This study will help us learn how well our updated COVID-19 vaccine works in babies and toddlers who have not been previously vaccinated and see if the number of recommended doses can potentially be reduced for children between 6 months to 23 months of age. 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 the newer COVID-19 variant called Omicron KP.2.
Children enrolled in this study will receive 2 doses of the updated COVID-19 vaccine. No children will receive a placebo (vaccine with no active ingredients). Doses will be given as an injection in the thigh.
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.
To see if your child may qualify to participate, click ‘Get started’.
Age
Children 6 to 23 months of age
Current Vaccination Status
No prior vaccines for COVID-19
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if your child qualifies to enroll in 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. 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 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
Your child will be enrolled for 8-9 months and will need to attend at least 2 study visits. Parents/guardians will also have at least 3 scheduled phone calls with the study team.
There is no cost to participate in this study, and health insurance is not required. You will also be compensated for completing study-related activities.
Number of vaccine doses
2 doses
Study Visit Schedule
5 visits over 8 - 9 months. 2 visits will be at the study clinic and 3 will be done by phone
Help make a difference
Rates of severe disease and hospitalizations for COVID-19 vary greatly by age for children, with children under 5 years having the greatest risk of being hospitalized.1 Race and ethnicity, family income levels, and where they live can also increase a child’s risk for severe illness.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. COVID Data Tracker. CDC. Accessed January 11, 2024.
https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network
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
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.
All children enrolled in the study will receive the updated COVID-19 vaccine for each dose. No children will receive a placebo (vaccine with no active ingredients).
At the beginning of the clinical trial, the study doctor will check your child’s overall health and medical history to see if this study is a good fit for them. The study team will give you more information about the tests and procedures during the review of the study’s informed consent document.
