NCT05056519

The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 3 Years – 59 Years
• Healthy volunteers: Accepted

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 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

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.

Conditions

• Influenza Prevention

Interventions

Type	Name	Description
BIOLOGICAL	Live Attenuated Influenza Vaccine	Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
BIOLOGICAL	Live Attenuated Influenza Vaccine placebo	Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.

Timeline

• Start date: 2021-09-20
• Primary completion: 2021-12-30
• Completion: 2022-03-30
• First posted: 2021-09-24
• Last updated: 2021-09-24

Locations

1 site across 1 country: China