SKYCellflu Quadrivalent Prefilled Syringe Adverse Reactions

Summary of safety profile: The safety of SKYCellflu Quadrivalent was assessed through phase I/II clinical trial and three phase III clinical trials. Four human clinical studies have been performed with SKYCellflu Quadrivalent and the safety was evaluated in the Safety Analysis Set of 1,506 subjects who were enrolled and received the vaccination with SKYCellflu Quadrivalent. Of 1,506 subjects who received the SKYCellflu Quadrivalent, and 449 healthy infant subjects, 255 healthy pediatric subjects and 802 healthy adult subjects received 0.5 mL. Safety evaluations were performed for all subjects during the first 3 weeks for adults or 4 weeks for pediatric subjects, 6 months to 18 years of age following vaccination. SAEs have been collected during six months of follow-up, except 449 subjects aged 6 through 35 months for whom SAE has been collected 1 month after vaccination.
Summary of adverse reactions: Local reaction: adverse reactions including injection site tenderness, pain, erythema/redness, and induration/swelling may occur; these reactions usually disappear instantly.
Systemic reaction: systemic reactions including myalgia, fatigue/malaise, headache, diarrhea, and vomiting may occur after vaccination; these reactions usually disappear within 3-4 days.
Encephalomyelitis: rarely, acute disseminated encephalomyelitis (ADEM) is reported. Fever, headache, convulsion, motor disorder, cognitive disorder, etc. may occur generally within 2 weeks after vaccination. In a case of suspected ADEM, diagnosis with MRI and proper intervention should be instituted.
Very rarely, allergic reaction to anaphylaxis may occur.
Temporary disorder of systemic and/or local neural network may occur. Sensitivity to stimulus or pain may be abnormal. Vascular, cerebral, or neuronal inflammation (e.g., Guillain-Barre syndrome) resulting in paralysis, neuropathic pain, bleeding, and internal bleeding has been reported.
Safety of SKYCellflu Quadrivalent was assessed in a study with 449 children 6 months through 35 months of age, 255 pediatric and adolescent subjects 3 through 18 years of age, and 802 adults ≥ 19 years of age, and followings were reported for adverse reactions. 701 out of 1,506 (46.55%) subjects developed adverse reactions after vaccination. The incidence rate was 50.11% in children 6 through 35 months of age, 46.27% in pediatric and adolescent subjects 3 through 18 years of age, 49.00% in adult 19 through 59 years of age, and 26.14% in subjects ≥ 60 years of age.
Solicited adverse reactions observed during the 7-day period after SKYCellflu Quadrivalent vaccination are shown as follows. (See Table 4.)

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Unsolicited adverse reactions observed during the 21-day (adults) or 28-day (children and adolescents) period after SKYCellflu Quadrivalent vaccination were reported in 35 out of 1,506 (2.32%) subjects. Adverse reactions related to respiratory system in 14 subjects (0.93%) was most frequently observed. Adverse reactions observed during the study period are shown as follows.
Uncommon: 0.1 to <5%, Rare: <0.1%. (See Table 5.)

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