To explore the immunogenicity and safety of quadrivalent split influenza virus vaccine in children aged 3-8 years with two doses and one dose. This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study. Sample size and test grouping: In this study, a total of 360 subjects were enrolled in a self-controlled trial design. In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group. All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation.
Sample size and test grouping: In this study, a total of 360 subjects were enrolled in a self-controlled trial design. In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group. All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation. The enrollment sequence of this study is divided into two stages: First stage: group 1, group 2 and group 3 into the group of 20 people, each agent 1 test vaccine respectively, collecting agent 1 test vaccine adverse event, within 7 days after 8 days after 1 dose diary collection card security assessment, confirm safe (not to suspend/terminate the test standard), can be on to the next stage into the group; The second dose of the trial vaccine was administered, adverse events were collected within 7 days after the second dose of the trial vaccine, diary cards were collected for safety assessment 8 days after the second dose, and the next phase of the second dose of vaccine could be administered after the safety was confirmed (criteria for suspension/termination of the trial were not met); The second stage: The remaining 100 subjects in experimental groups 1, 2 and 3 were inoculated with the first and second doses of experimental vaccine. Blood collection procedure: About 4.0ml of venous blood was collected from all subjects before each dose and 30 days after the second dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
360
Prevent influenza caused by H1N1, H3N2, B (V), B (Y) strain virus infection.
Yangchun Center for Disease Control and Prevention
Guangzhou, Guangdong, China
Seroconversion Rate (SCR)
Seroconversion Rate (SCR) of HI antibodies of 4 vaccine strain types in all subjects
Time frame: 28 days after the first dose of trial vaccine,30 days after the second dose of trial vaccine.
Seroprotection Rate (SPR)
Seroprotection Rate (SPR) of HI antibodies of 4 vaccine types in all subjects
Time frame: 28 days after the first dose of trial vaccine, 30 days after the second dose of trial vaccine.
Geometric Mean Titer
Geometric Mean Titer of HI antibodies of 4 vaccine types in all subjects
Time frame: 28 days after the first dose of trial vaccine,30 days after the second dose of trial vaccine.
Incidence of adverse reactions
Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation
Time frame: Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation
Incidence of all adverse events
• Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;
Time frame: • Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;
Incidence of all serious adverse events
Incidence of all serious adverse events from the first dose to 6 months after full vaccination;
Time frame: Incidence of all serious adverse events from the first dose to 6 months after full vaccination;
Incidence of AE/SAE leading to withdrawal.
Incidence of AE/SAE leading to withdrawal.
Time frame: Incidence of AE/SAE leading to withdrawal within seven month during the study period
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