The purpose of this clinical trial is to learn about the safety and immune responses of the study vaccine (called a bivalent BNT162b2 Omicron containing vaccine) in healthy infants and children. Sub study A of this clinical trial will test up to four different dose levels of the vaccine in infants who are under 6 months of age and have not previously received a coronavirus vaccination. This will be a 3- dose primary series of the study vaccine with each dose separated by 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Injection in the muscle
Injection in the muscle
Injection in the muscle
Substudy A - Percentage of participants reporting local reactions in each dose level
Tenderness at the injection site, redness, and swelling as self-reported on electronic diaries.
Time frame: For 7 days following Dose 1, Dose 2, Dose 3
Substudy A - Percentage of participants reporting systemic events in each dose level
Fever, decreased appetite, drowsiness, and irritability as self-reported on electronic diaries.
Time frame: For 7 days following Dose 1, Dose 2 and Dose 3
Substudy A - Percentage of participants reporting adverse events in each dose level
As elicited by investigational site staff
Time frame: Dose 1 through 1 month after Dose 3
Substudy A - Percentage of participants reporting serious adverse events in each dose level
As elicited by investigational site staff
Time frame: Dose 1 through 6 months after Dose 3
Substudy A - Geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants < 6 months of age
As measured at the central laboratory
Time frame: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3
Substudy A - Geometric mean fold rise elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants < 6 months of age
As measured at the central laboratory
Time frame: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3
Substudy A - Percentage of participants with seroresponse elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants < 6 months of age
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Injection in the muscle
As measured at the central laboratory
Time frame: At baseline (before Dose 1), 1 month after Dose 2, and 1 month after Dose 3