This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age (-14/+14 days) at first trial vaccine administration. In this protocol, because the trial is blinded, trial vaccine refers to both the investigational vaccine (HIL-214) and placebo.
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Safety of HIL-214 Compared to Placebo - AEs Leading to Trial Withdrawal
Timeframe: Day 1 to 6 months post-dose 2
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events
Timeframe: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2 (Day 36 to Day 56)
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events
Timeframe: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2 (Day 36 to Day 56)
Safety of HIL-214 Compared to Placebo - Percentage of Participants With AEs Leading to Vaccine Withdrawal
Timeframe: Up to 56 days post-dose 1