The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine
NCT05284851
Phase
Phase 2
Recruitment status
Unknown
Participants
2,520
Lead sponsor
Changchun BCHT Biotechnology Co.
Start date
2022-04-01
Number of sites
- 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).
- Short title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2022-10-01
- First posted
- 2022-03-17
- Registry last updated
- 2022-03-17
- Primary completion date
- 2022-05-01
- Start date
- 2022-04-01
- Participants
- 2,520
- Participant count basis
- Estimated
- Planned participants
- 2,520
- Protocol amendments
- Randomisation ratio
- 2:2:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05284851
- ClinicalTrials.gov ID
- NCT05284851
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Single masking
- 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 .
- Masked roles
- Participants
Sources for study design
The number of participants with positive sIgA as assessed by SAS v9.4
Timeframe: within 10 days after vaccination
The Mucosal convention rate of sIgA in all subjects
Sources for outcomes
- Sex
- All
- Age groups
- Children, Adults
- Minimum age
- 3 Years
- Maximum age
- 59 Years
- Healthy volunteers
- Yes
- 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
- 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
Sources for eligibility
- Hebei Provincial Center for Disease Control and PreventionShijiazhuang, China
Sources for sites
Related records
Drugs (1)
Collaborators (1)
- He Bei province Center for Disease control and prevention