Safety
myalgia, fever, Guillain, erythema, pain, non-febrile, headache, Barré syndrome, febrile
GENERALIZED SEIZURES, ADVERSE EVENTS, ADVERSE EVENT, ERYTHEMA, IDIOPATHIC THROMBOCYTOPENIA PURPURA, ADVERSE EVENT, HAND SWELLING, KAWASAKI DISEASE
Participants were observed for 30 min after vaccination to ensure their safety, during which, any unsolicited systemic adverse event (AE) was recorded. The occurrence of solicited injection site (pain, erythema and swelling) and systemic reactions (fever, headache, malaise and myalgia) were recorded up to 7 days after vaccination in the participant’s diary card provided to the parents/guardians. Parents or guardians were asked to inform the investigators of any potential serious adverse events (SAEs) immediately.Unsolicited AEs were collected from Day 0 to Day 30 and medically attended AEs (MAAEs) and (SAEs) including AEs of special interest (AESIs) were recorded throughout the study (up to the 6-month [+14 days] follow-up phone call). Adverse events classified as AESIs were generalized seizures (febrile and non-febrile), Kawasaki disease, Guillain–Barré syndrome and idiopathic thrombocytopenia purpura.Adverse events were assessed by the investigator for relatedness to the study vaccine and for intensity (grade 1 intensity [mild] to grade 3 [severe; interrupts usual daily activity]).