Pediatric COVID Vaccine

Purpose:

Because children can become seriously ill from COVID-19, the Centers for Disease Control and Prevention (CDC) recommends COVID-19 vaccines for all children over 6 months old. As COVID-19 variants like Omicron continue to emerge, approval of a bivalent vaccine for children that aims to increase immunity against both current and future variants may be key for protecting them against COVID-19. “Bivalent” means a combination of two different variant types are targeted in a single shot.

The vaccine being studied is a combination of the original Pfizer & BioNTech vaccine (BNT162b2Original) and an investigational vaccine targeting Omicron subtypes BA.4 and BA.5 (BNT162b2 Omicron BA.4/ BA.5).

AN IMPORTANT CONTRIBUTION:

Before a new vaccine can be approved for children, it must first be tested in a series of clinical trials. Without the help of clinical trial participants, we would not have any of the vaccines or medicines we use today. 

By choosing to volunteer, your child will receive an investigational vaccine that may provide more comprehensive and longer-lasting protection against COVID-19 while representing others like them – in age, gender, race, ethnicity, and from communities like yours. Including people from all backgrounds will help us develop a COVID-19 vaccine that is more likely to be effective for everyone.

Joining a clinical trial is an important and personal decision for your family. Thank you for considering this study.

WHAT TO EXPECT

  • All participants will receive 4 doses of the study vaccine given as an injection in the upper arm or thigh. This study does not include a placebo (product with no active ingredient).
  • Participants will be enrolled in the study for about 1 year and 3 or 4 months and will need to attend about 8 study visits (1 visit is by phone), including 4 blood draws. Parents/guardians will also need to complete entries in an electronic diary (eDiary) throughout the study.
  • Parents/guardians may be reimbursed for expenses related to participants’ time in the study.

Visit COVIDVACCINESTUDY.COM, contact our site by calling 937-534-4238, or fill out an interest form to learn more.