Influenza Prevention
Conditions
Keywords
Immunogenicity, Safety, Live Attenuated Influenza Vaccine
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.
Interventions
BIOLOGICALLive Attenuated Influenza Vaccine(non freeze-dried)
Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
BIOLOGICALLive Attenuated Influenza Vaccine(freeze-dried)
Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.
Sponsors
He Bei province Center for Disease control and prevention
Changchun BCHT Biotechnology Co.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The design of this trail is based on random, one-blind, placebo control. The subjects will not know the masking status, unless the specific subjects who required treatment for serious adverse events .
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants with positive sIgA as assessed by SAS v9.4 | within 10 days after vaccination | The Mucosal convention rate of sIgA in all subjects |
Countries
China
Outcome results
None listed