This post-marketing study is a multicenter cohort study in pregnant women vaccinated with Abrysvo (RSV vaccine)designed to confirm the safety in pregnant women and their infants under actual clinical practice in Japan.
Study Type
OBSERVATIONAL
Enrollment
497
Injection in the muscle, 1 dose 0.5mL
Pfizer
Tokyo, Japan
Percentage of pregnant women reporting Adverse Reactions for 28 days after vaccination
Time frame: up to 28 days after vaccination
Percentage of pregnant women reporting Serious Adverse Reactions from the day of vaccination up to 28 days after delivery
Time frame: up to 28 days after delivery
Percentage of pregnant women reporting reactogenicity events (local reactions and systemic events) from day of vaccination up to 7 days after vaccination
Time frame: up to 7 days after vaccination
Percentage of infants reporting Adverse Reactions from the birthday up to 28 days after birth
Time frame: up to 28 days after birth
Percentage of infants reporting Serious Adverse Reactions from the birthday up to 28 days after birth
Time frame: up to 28 days after birth
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