This randomized, placebo-controlled, double-blind, safety and dose-finding Phase Ia trial will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule.
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Frequency of solicited local reactions (pain, erythema/redness, induration/swelling) at the injection site up to 7 days after each dose
Timeframe: Up to 7 days after each dose
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue, muscle pain and joint pain, chills, and fever) up to 7 days after each dose
Timeframe: Up to 7 days after each dose
Proportion of participants with at least one adverse event (AE) occurring from each dose to 28 days after each dose
Timeframe: From Day 1 until Day 197
Proportion of participants with at least one AE occurring from Dose 1 to 28 days post-Dose 3
Timeframe: From Day 1 until Day 197
Proportion of participants with at least one serious adverse event (SAE) or medically attended adverse event (MAAE) occurring from Dose 1 up to 168 days post-Dose 3
Timeframe: From Day 1 until Day 337
Number of AEs from Dose 1 to 28 days post-Dose 3
Timeframe: From Day 1 until Day 197