Condition or diseaseīiological: BNT162b1 Biological: BNT162b2 Other: Placebo Biological: BNT162b2SA To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. ![]() Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age Phase 2/3: ≥12 years of age ).At various different dose levels in Phase 1.As a 2-dose (separated by 21 days) schedule.The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: ![]() The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s) Phase 2/3: an expanded cohort and efficacy part. This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. Why Should I Register and Submit Results?.
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