The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Influenza Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056519
• Other study ID #: F20210719
• Status: Recruiting
• Phase: Phase 1
• Start date: September 20, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: September 2021
• 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 30, 2022
• Est. primary completion date: December 30, 2021
• 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 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

Related Conditions & MeSH terms

• Influenza Prevention
• Influenza, Human

Intervention

Biological:
• 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	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
Primary	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
Primary	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