Clinical trial NCT05284851: The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Influenza Prevention
Keywords: Immunogenicity
Safety
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: 2022-03-17
Enrollment: 2520
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 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.
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of participants with positive sIgA as assessed by SAS v9.4
timeFrame: within 10 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: