Status:
UNKNOWN
The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine
Lead Sponsor:
Changchun BCHT Biotechnology Co.
Collaborating Sponsors:
He Bei province Center for Disease control and prevention
Conditions:
Influenza Prevention
Eligibility:
All Genders
3-59 years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
2520 Patients enrolled
Trial Details
Trial ID
NCT05284851
Start Date
April 1 2022
End Date
October 1 2022
Last Update
March 17 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China, 050021