EraPolio Adverse Reactions

In phase Ⅰ, Ⅱ and Ⅲ pre-licensure clinical trials, 739 infants were administered this product for three doses of primary vaccination, among which 541 infants in the phase Ⅲ clinical trial completed one booster dose at the age of 18 months. Systematic safety follow-up observation was carried out within 7 days after each dose vaccination, and adverse events were collected through subjects' spontaneous reports and investigators' regular follow-up within 8-30 days after each dose; meanwhile, serious adverse events were collected within 0-30 days after vaccination in all the clinical trials, as well as the period from 30 days after the primary vaccination till 30 days after the booster vaccination in the phase Ⅲ clinical trial.
According to the grading standard of adverse reaction incidence from the Council for International Organizations of Medical Sciences (CIOMS), i.e. very common (≥10%), common (≥1% and <10%), uncommon (≥0.1% and <1%), rare (≥0.01% and <0.1%) and very rare (<0.01%), the adverse reactions are classified as follows: System adverse reaction: Very common: Fever (≥37.1°C) and diarrhea.
Common: Nausea, vomiting, decreased appetite, and abnormal activity level.
Uncommon: Hypersensitivity, crying, irritability, drowsiness, pruritus, rash, erythema, and conjunctival congestion.
Local adverse reaction: Common: Redness, swelling, and induration .
Uncommon: Pruritus and rash.
Serious adverse reaction: 63.64% adverse reactions above were mild and 35.33% were moderate. During the clinical trials, no serious adverse events related to this product occurred.