Clinical trial NCT05056519: The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Influenza Prevention
Keywords: Safety
Immunogenicity
Live Attenuated Influenza Vaccine
Lead sponsor: Changchun BCHT Biotechnology Co.
Sponsor class: INDUSTRY
Collaborators: name: He Bei province Center for Disease control and prevention
First posted: 2021-09-24
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Totally 160 in 3-59 years old healthy people will be divided into two age group, which contain 80 people in 18-59 years old and 80 people in 3-17 years old. In each age group, subjects will be randomly divided into vaccine group and placebo group in a ratio of 3:1.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events as assessed by SAS v9.4
timeFrame: Within 31 days after vaccination
measure: Number of participants with laboratory examination abnormity as assessed by SAS v9.4Clinical laboratory examination
timeFrame: 3 days after vaccination
measure: Number of participants with virus Shedding as assessed by SAS v9.4
timeFrame: within 16 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang Shi
country: China
facility: Hebei Provincial Center for Disease Control and Prevention
state: Hebei
Study officials:
References: