The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Changchun BCHT Biotechnology

Status and phase

Unknown

Phase 1

Conditions

Influenza Prevention

Treatments

Biological: Live Attenuated Influenza Vaccine placebo

Biological: Live Attenuated Influenza Vaccine

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05056519

F20210719

Details and patient eligibility

About

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).

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

3 to 59 years old

Volunteers

Accepts Healthy Volunteers

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