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 variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. * Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in. * Substudy B design: includes participants 6 months through less than 5 years of age 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: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. * Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy E design: includes participants 5 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine.
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Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions
Timeframe: for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4
SSA - Ph 1 dose finding, percentage of participants reporting systemic events
Timeframe: for up to 7 days following Dose 1, Dose 2, Dose 3 and Dose 4
SSA - Ph 1 dose finding, percentage of participants reporting adverse events
Timeframe: from Dose 1 to 1 month after Dose 3 and from Dose 4 to 1 month after Dose 4
SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events
Timeframe: from Dose 1 to 6 months after the last dose
SSA - Ph 2/3, percentage of participants reporting local reactions
Timeframe: for up to 7 days following Dose 1 (for Groups 1 through 6), Dose 2 (for Groups 1, 2, 3, and 6), and Dose 3 (for Group 3)
SSA - Ph 2/3, percentage of participants reporting systemic events
Timeframe: for up to 7 days following Dose 1 (for Groups 1 through 6), Dose 2 (for Groups 1, 2, 3, and 6), and Dose 3 (for Group 3)
SSA - Ph 2/3, percentage of participants reporting adverse events
Timeframe: from Dose 1 to 1 month after the last dose
SSA - Ph 2/3, percentage of participants reporting serious adverse events
Timeframe: from Dose 1 to 6 months after the last dose
SSA - Ph 2/3, noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers in participants ≥6 months to <2 years of age
Timeframe: At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) 10 microgram (on a 0- and 8-week schedule) to 1 month after 3 doses (on a 0-, 3-, and 11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram
SSA - Ph 2/3, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain titers in participants ≥6 months to <2 years of age
Timeframe: At 1 month after 2 doses of BNT162b2 (Omicron XBB.1.5) 10 microgram (on a 0- and 8-week schedule) and at 1 month after 3 doses (on a 0-, 3-, and 11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram
SSA - Ph 2/3, noninferiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers in participants ≥2 to <5 years of age
Timeframe: At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥2 to <5 years of age to 1 month after 3 doses (on a 0/3/11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram in participants ≥6 months to <2 years of age
SSA - Ph 2/3, noninferiority with respect to seroresponse rate to the Omicron XBB.1.5 strain in participants ≥2 to <5 years of age
Timeframe: At 1 month after 1 dose of BNT162b2 (Omicron XBB.1.5) 10 microgram in participants ≥2 to <5 years of age and at 1 month after 3 doses (0/3/11-week schedule) of BNT162b2 (Omicron XBB.1.5) 3 microgram in participants ≥6 months to <2 years of age
Substudy B (SSB) - percentage of participants reporting local reactions
Timeframe: for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)
SSB - percentage of participants reporting systemic events
Timeframe: for up to 7 days following Dose 1 (for Groups 1, 2 and 3) and Dose 2 (for Group 1)
SSB - percentage of participants reporting adverse events
Timeframe: from the first study vaccination to 1 month after the first study vaccination (for Groups 1, 2, and 3), and from the second study vaccination to 1 month after the second study vaccination (for Group 1 only)
SSB - percentage of participants reporting serious adverse events
Timeframe: from Dose 1 to 6 months after the last dose
SSB - superiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age
Timeframe: at 1 month after Dose 4 for Group 2 participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to 1 month after Dose 3 in Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg
SSB - noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age
Timeframe: at 1 month after Dose 4 for Group 2 participants who received 3 prior doses of BNT162b2 3 µg and a fourth dose of bivalent BNT162b2 to 1 month after Dose 3 in Study C4591007 participants ≥6 months to <5 years of age who received 3 doses of BNT162b2 3 µg
Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions
Timeframe: for up to 7 days following Dose 1
SSC - Ph 1 dose finding, percentage of participants reporting systemic events
Timeframe: for up to 7 days following Dose 1
SSC - Ph 1 dose finding, percentage of participants reporting adverse events
Timeframe: 1 month after Dose 1
SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events
Timeframe: 6 months after Dose 1
SSC - Ph 1 dose finding - geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age
Timeframe: At baseline (before Dose 1) and 1 month after Dose 1
SSC - Ph 1 dose finding - geometric mean fold rise elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age
Timeframe: At baseline (before Dose 1) and 1 month after Dose 1
SSC - Ph 1 dose finding - percentage of participants with seroresponse elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age
Timeframe: At baseline (before Dose 1) and 1 month after Dose 1
Substudy D (SSD) - percentage of participants reporting local reactions
Timeframe: for up to 7 days following Dose 1
SSD - percentage of participants reporting systemic events
Timeframe: for up to 7 days following Dose 1
SSD - percentage of participants reporting adverse events
Timeframe: 1 month after Dose 1
SSD - percentage of participants reporting serious adverse events
Timeframe: 6 months after Dose 1
SSD - the ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥5 to <12 years of age
Timeframe: at 1 month after Dose 4 for participants who received 3 prior doses of BNT162b2 10 μg and a fourth dose of bivalent BNT162b2 to those at 1 month after Dose 3 for Study C4591007 Phase 2/3 participants who received 3 doses of BNT162b2 10 μg
SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥5 to <12 years of age
Timeframe: at 1 month after bivalent BNT162b2 as a fourth dose for participants who received 3 prior doses of BNT162b2 10 µg and at 1 month after a third dose of BNT162b2 10 µg for Study C4591007 Phase 2/3 participants who received 3 doses of BNT162b2 10 µg
Substudy E (SSE) - percentage of participants reporting local reactions
Timeframe: for up to 7 days following Dose 1
SSE - percentage of participants reporting systemic events
Timeframe: for up to 7 days following Dose 1
SSE - percentage of participants reporting adverse events
Timeframe: from Dose 1 to 1 month after Dose 1
SSE - percentage of participants reporting serious adverse events
Timeframe: from Dose 1 to 6 months after Dose 1
SSE - Ratio of the geometric mean of SARS-CoV-2 Omicron XBB.1.5-neutralizing titers
Timeframe: At 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 10 microgram in participants ≥5 to 12 years of age to 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 30 microgram in participants ≥12 years of age from study C4591054 Substudy A
SSE - difference in percentage of participants with seroresponse to Omicron XBB.1.5
Timeframe: At 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 10 microgram in participants ≥5 to 12 years of age and 1 month after 1 dose of BNT162b2 (Omi XBB.1.5) 30 microgram in participants ≥12 years of age from study C4591054 Substudy A