The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Phase 2

• Conditions: Influenza Prevention
• Interventions: Biological: Live Attenuated Influenza Vaccine placebo; Biological: Live Attenuated Influenza Vaccine(freeze-dried); Biological: Live Attenuated Influenza Vaccine(non freeze-dried)

• Registration Number: NCT05284851
• Lead Sponsor: Changchun BCHT Biotechnology Co.

Brief Summary

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 two trail is to evaluate the immunogenicity of LAVI (non freeze- dried). The secondary objective is to evaluate the safety of LAVI (non freeze- dried).

Detailed Description

Totally 2520 health people aged 3-59 years old will be divided into two age group, containing 1260 in 18-59 years old and 1260 in 3-19 years old. All subjects will receive vaccination either LAVI(non freeze- dried), LAVI(freeze- dried) or placebo in a ratio of 2:2:1.

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-09
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17
• Study Start: 2022-04-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2520

Inclusion Criteria

• Healthy volunteers aged in 3-59 years old
• Had not received vaccination of Influenza vaccine in the past one year
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Live Attenuated Influenza Vaccine placebo	Healthy people in placebo group will receive a dose of placebo
Positive control group	Live Attenuated Influenza Vaccine(freeze-dried)	Healthy people in Positive control group will receive a dose of Live Attenuated Influenza Vaccine ( freeze- dried)
Experimental group 1	Live Attenuated Influenza Vaccine(non freeze-dried)	Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine (non freeze- dried)

Primary Outcome Measures

Name	Time	Method
The number of participants with positive sIgA as assessed by SAS v9.4	within 10 days after vaccination	The Mucosal convention rate of sIgA in all subjects

Trial Locations

Locations (1)

Hebei Provincial Center for Disease Control and Prevention; 🇨🇳 Shijiazhuang Shi, Hebei, China