Live Attenuated freeze-dried Influenza Vaccine has been licensed for use in 2020 (Approval No.S20200002), the sponsor of this research submitted an new application for non freeze-dried Live Attenuated Influenza Vaccine in 2021. The main objective of phase Ⅰ trail is to evaluate the safety of LAVI(non freeze-dried). The secondary objective is to evaluate the immunogenicity of LAVI(non freeze-dried).
Totally 160 health people aged 3-59 years old will be divided into two age group, containing 80 in 18-59 years old and 80 in 3-19 years old. All subjects will receive vaccination either LAVI or placebo in a ratio of 3:1. All subjects will be collected any adverse events within 30 days and any serious adverse events within 6 months for safety evaluation. All subjects will be collected blood sample and nasopharyngeal swab for immunogenicity evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
160
Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
RECRUITINGNumber of participants with adverse events as assessed by SAS v9.4
The incidence rate of adverse events in all subjects
Time frame: Within 31 days after vaccination
Number of participants with laboratory examination abnormity as assessed by SAS v9.4Clinical laboratory examination
The incidence rate of abnormal of Blood routine, blood biochemical and urine in The incidence rate of abnormality of blood routine, blood biochemical and urine routine in 18-59 years age group
Time frame: 3 days after vaccination
Number of participants with virus Shedding as assessed by SAS v9.4
The nasal secretions of Subjects in 18-59 years age group will be taken and be tested
Time frame: within 16 days after vaccination
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