The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Influenza Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05284851
• Other study ID #: Bchtpharm
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2022
• Source: Changchun BCHT Biotechnology Co.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2520
• Est. completion date: October 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza Prevention
• Influenza, Human

Intervention

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.
• 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.
• Live Attenuated Influenza Vaccine placebo
Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.

Locations

Country	Name	City	State
China	Hebei Provincial Center for Disease Control and Prevention	Shijiazhuang Shi	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Changchun BCHT Biotechnology Co.	He Bei province Center for Disease control and prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with positive sIgA as assessed by SAS v9.4	The Mucosal convention rate of sIgA in all subjects	within 10 days after vaccination