A Study to Evaluate Additional Dose(s) of BNT162b2 in Healthy Individuals Previously Vaccinated With BNT162b2

INTERVENTION: Trade Name: COMIRNATY Product Name: BNT162b2 Product Code: RBP020.2 (PF‐07302048) Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Tozinameran Current Sponsor code: BNT162b2 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 500‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use CONDITION: Protection against COVID‐19 ; MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] SECONDARY OUTCOME: Secondary end point(s): Substudy A; Secondary Efficacy; ‐ Confirmed severe COVID‐19 (based on FDA definition) incidence from 7 days after the booster dose per 1000 person‐years of blinded follow‐up ; ‐ Incidence of asymptomatic SARS‐CoV‐2 infection per 1000 person‐years of follow‐up based on N‐binding antibody seroconversion; ; Sustudy B; Not applicable.; ; Substudy C; Secondary Immunogenicity; ‐ SARS‐CoV‐2 neutralizing titers Timepoint(s) of evaluation of this end point: Please, see Protocol Section 3, Section 10.7.3; Section 10.8.3 and Section 10.9.3. INCLUSION CRITERIA: Participants are eligible to be included in the study only if all of the substudy‐specific inclusion criteria are met. For Substudy A, see Section 10.7.5.1. of the Study Protocol; For Substudy B, see Section 10.8.5.1. of the Study Protocol; For Substudy C, see Section 10.9.5.1. of the Study Protocol. Some inclusion criteria are common to all substudies: participants (and their parent(s)/legal guardian(s) willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures; participants should be healthy; and participants (or their parent[s]/legal guardian[s]) must be capable of giving personal signed informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 1188 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 10172 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26 PRIMARY OUTCOME: Main Objective: Substudy A; Primary Efficacy; ‐ To describe the efficacy of a booster dose of BNT162b2 against confirmed COVID‐19 occurring from 7 days after the booster dose through the blinded follow‐up period in participants without evidence of past SARS‐CoV‐2 infection; ‐ For further primary objectives of Substudy A, please refer to Protocol Section 10.7.3.; ; Substudy B; Primary Safety; ‐ To describe the frequency of elevated troponin I levels before and after a booster dose of BNT162b2 or placebo; ‐ To define the safety profile of a booster dose of BNT162b2; ; Substudy C; Primary Safety; ‐ To evaluate the safety of a booster dose of BNT162b2 when administered at both 10‐µg and 30‐µg doses; Primary Immugeniticy; ‐ For Primary Immunogenicty objectives of Substudy C, please refer to Protocol Section 10.9.3. Primary end point(s): Substudy A; Primary Efficacy; Confirmed COVID‐19 incidence from 7 days after the booster dose per 1000 person‐years of blinded follow‐up; ; Primary Safety; ‐ AEs; ‐ SAEs; ; Substudy B; Primary Safety ; ‐ Troponin I level; ‐ Local reactions (pain at the injection site, redness, and swelling); ‐ Systemic events (fever, fatigue/tiredness, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain); ‐ AEs; ‐ SAEs; ; Substudy C; Primary Efficacy; ‐ Local reactions (pain at the injection site, redness, and swelling); ‐ Systemic events (fever, fatigue/tiredness, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain); ‐ AEs; ‐ SAEs; ; Primary Immunogenicity; ‐ SARS‐CoV‐2 neutralizing titers Secondary Objective: Substudy A; Secondary Efficacy; ‐ To describe the efficacy of a booster dose of BNT162b2 against confirmed severe COVID‐19 (based on FDA definition) occurring from 7 days after the booster dose through the blinded follow‐up period in participants without evidence of past SARS‐CoV‐2 infection; ‐ To describe the efficacy of a booster dose of BNT162b2 against confirmed severe COVID‐19 (based on FDA definition) occurring from 7 days after the booster dose through the blinded follow‐up period in participants with and without evidence of past SARS‐CoV‐2 infection; ‐ For further Secondary objectives of Substudy A, please refer to Section 10.7.3 of the protocol.; ; Substudy B; ‐ Not available on the Protocol; ; Substudy C; Secondary Immunogenicity; ‐ To describe the immune responses induced by a booster (third) dose of BNT162b2 at 10 µg and 30 µg Timepoint(s) of evaluation of this end point: Please, see Protocol Section 3, Section 10.7.3; Section 10.8.3 and Section 10.9.3.;