The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Random, Double -Blind, Placebo Control Phase Ⅰ Trail to Evaluate the Safety and Immunogenicity of Live Attenuated Influenza Vaccine in 3-59y Healthy People

Conditions
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Influenza Prevention

Intervention / Treatment
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* Biological: Live Attenuated Influenza Vaccine
* Biological: Live Attenuated Influenza Vaccine placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged in 3-59 years old. Had not received vaccination of Influenza vaccine in the past half of years. Had not infected with Influenza virus. This trail has been agreed by volunteers or his/her legal guardian. Volunteers or his/her legal guardian will fellow this trail protocol. Exclusion Criteria: People from 18-59 age group with abnormal laboratory index. (slight abnormality is except if judged with no clinical significance by doctors.) People with fever before vaccination, temperature higher than 37.0 ℃ Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials. Acute infectious disease or acute attack of chronic disease before inoculation People get any vaccine within 14 days before the trial. People in immune deficiency or diagnosed with congenital or acquired immunodeficiency, people with immunosuppressive therapy in the past six months. People with epilepsy or a history of mental illness

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Totally 160 in 3-59 years old healthy people will be divided into two age group, which contain 80 people in 18-59 years old and 80 people in 3-17 years old. In each age group, subjects will be randomly divided into vaccine group and placebo group in a ratio of 3:1.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine | Biological: Live Attenuated Influenza Vaccine<br>* Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.<br>|
| Placebo Comparator: Placebo group<br>Healthy people in placebo group will receive a dose of placebo | Biological: Live Attenuated Influenza Vaccine placebo<br>* Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as assessed by SAS v9.4 | The incidence rate of adverse events in all subjects | 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 | 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 | within 16 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Immunogenicity, Live Attenuated Influenza Vaccine