Pursuing Longer Lasting Protection Against COVID-19
While most children do not become seriously ill from COVID-19, some do and require hospitalization. Children can still infect others and may be at risk of developing MIS-C, a rare but life-threatening inflammatory condition related to COVID-19. As new variants like Omicron continue to emerge, approval of a bivalent vaccine for children that aims to increase immunity against current and future variants may be key for protecting them against COVID-19. This study is evaluating the safety and immune response generated by an investigational bivalent COVID-19 vaccine as a primary 3-dose series plus booster in healthy infants and children under 5 who have not previously been vaccinated for COVID-19. The study vaccine is a combination of the original Pfizer & BioNTech vaccine (BNT162b2 Original) and an investigational vaccine for Omicron subtypes BA.4 and BA.5 (BNT162b2 Omicron BA.4/BA.5).
Who can participate?
Joining a clinical trial is an important decision for your family. Thank you for considering this study.
This study may be an option for infants and children who:
- Are 6 months to less than 4 years and 3 months
- Are generally healthy or have stable chronic medical conditions
- Have not received a COVID-19 vaccine
There are other requirements to join this clinical study. A study team member will help determine if this study is right for your child based on all participation criteria.
What to Expect
This study does not include a placebo (product with no active ingredient). All participants will receive 4 doses of the study vaccine. Participants will be enrolled in the study between approximately 1 year and 3 months to 1 year and 4 months and will need to attend 8 study visits (1 is by telephone), including 4 blood draws. Parents/guardians may be reimbursed for expenses related to participants’ time in the study.
What Are Clinical Trials?
A clinical trial is a type of research study that collects new information and answers researchers’ questions about health and disease. While most medicines are used to help people who are already sick, vaccines are meant to keep people from getting sick. All new vaccines need to be tested in a series of clinical trials before they can be available to the public.
What is the Study Vaccine?
The study vaccine is a combination of the original Pfizer & BioNTech COVID-19 vaccine (BNT162b2Original) and an investigational Omicron vaccine with modifications that may improve its effectiveness against newer subtypes (BNT162b2 Omicron BA.4/BA.5).
Contact a Study Team Member to Learn More
If you are interested in learning more about this clinical trial, please reach out to your local study site using the contact information below. The study team can answer all your questions to see if your child may qualify.