NCT05284851

The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,520 (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 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.

Conditions

• Influenza Prevention

Interventions

Type	Name	Description
BIOLOGICAL	Live Attenuated Influenza Vaccine(non freeze-dried)	Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
BIOLOGICAL	Live Attenuated Influenza Vaccine(freeze-dried)	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: 2022-04-01
• Primary completion: 2022-05-01
• Completion: 2022-10-01
• First posted: 2022-03-17
• Last updated: 2022-03-17

Locations

1 site across 1 country: China