GCP Clinical Trial
Official title:
The Shandong Provincial Center for Disease Control and Prevention, China
The goal of this [To evaluate the immunogenicity and safety of 1 - and 2-dose schedules of quadrivalent influenza vaccine (split virion) in healthy people with and without immunization history.] is to [aged 3-8 years] in [Healthy people]. The main question[s] it aims to answer are: • [To evaluate the immunogenicity of a two-dose schedule of quadrivalent influenza vaccine (quadrivalent influenza vaccine) in healthy population aged 3-8 years with or without vaccination history.] •[ To evaluate whether antibody levels are different 30 days after one dose of quadrivalent influenza vaccine versus two doses of quadrivalent influenza vaccine in healthy people aged 3-8 years with or without vaccination history.]
An open clinical trial design was used. A total of 652 healthy children aged 3-8 years, 326 with vaccination history and 326 without vaccination history, were selected to receive two doses of normal commercially available quadrivalent influenza vaccine according to a 0 -, 30-day schedule. Immunogenicity: blood samples were collected for HI antibody detection before the first dose of influenza vaccine (before immunization), 30 days after the first dose of influenza vaccine (before the second dose of influenza vaccine) and 30 days after the second dose of influenza vaccine. Adverse events (AE) were observed 30 minutes, 0-7 days and 8-30 days after each dose of vaccination by active follow-up combined with guardian reports. Occurrence of SAEs between 31 and 180 days after the second dose of vaccine. Criteria for evaluation of immunogenicity According to the European Union seasonal influenza evaluation criteria, if the HI antibody seroconversion rate of each subtype of influenza virus was ≥40%, the HI antibody positive rate was ≥70%, and the GMI of each subtype of influenza virus was ≥2.5 times 30 days after any dose of vaccination, the vaccination schedule was considered to have acceptable immunogenicity. Safety outcome MEASURES The occurrence of adverse reactions/events after each dose of vaccination was observed. The incidence of ① total adverse reactions/events, ② incidence of grade 3 or above adverse reactions/events and SAE, ③ incidence of adverse reactions/events severity classification, ④ incidence of adverse reactions/events by type (inoculation site and systemic, SOC, PT) and incidence of adverse reactions/events severity classification were calculated. Note: Known adverse effects of quadrivalent influenza vaccine that have been identified in previous clinical studies are as follows: Inoculation site (local) adverse events: pain, induration, swelling, rash, redness, pruritus, cellulitis. Adverse events at non-inoculated sites (systemic) included fever, diarrhea, constipation, dysphagia, anorexia, vomiting, nausea, myalgia (non-inoculated sites), arthralgia, headache, cough, dyspnea, pruritus at non-inoculated sites (without skin lesions), mucocutaneous abnormalities, irritation/inhibition, acute anaphylaxis, and fatigue/fatigue. ;