The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called bivalent BNT162b2 Omicron containing vaccine) in healthy children. The trial is divided into 4 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 4 sub-studies study vaccine as a shot depending on what group they are in. Substudy A design: includes participants 6 months through 23 months who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial which may be followed by a fourth dose of study vaccine. Substudy B design: includes 6 months through 4 years who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. Substudy C design: includes participants 6 months through 4 years who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. Substudy D design: includes participants 5 through 12 years who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.
39 Primary · 15 Secondary · Reporting Duration: Group 1: At baseline (before Dose 1), 1 month after Dose 1 and 1 month after Dose 2; Groups 2 and 3: At baseline (before Dose 1) and 1 month after Dose 1
2270 Total Participants · 14 Treatment Groups
Primary Treatment: 10 microgram dose, 5 to <12 Years (Substudy D, Group 1) · No Placebo Group · Phase 2 & 3
Age < 18 · All Participants · 2 Total Inclusion CriteriaMark “Yes” if the following statements are true for you: