> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/the-safety-and-immunogenicity-evaluation-of-live-attenuated-60aa0c5b-db02-4a2d-86d2-902c51f602bc > Record changed: 2026-10-13 # The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine NCT05284851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) Participants 2,520 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) Lead sponsor Changchun BCHT Biotechnology Co. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) Start date 2022-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Short title** The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Dates **Completion date** 2022-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **First posted** 2022-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Registry last updated** 2022-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Primary completion date** 2022-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Start date** 2022-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Size and sites **Participants** 2,520 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Planned participants** 2,520 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Randomisation ratio** 2:2:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Lead sponsor** Changchun BCHT Biotechnology Co. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Identifiers **Registry ID** NCT05284851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **ClinicalTrials.gov ID** NCT05284851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Study design **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Outcomes ### Primary outcomes 1. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Eligibility **Sex** All **Age groups** Children, Adults **Minimum age** 3 Years **Maximum age** 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Sites - Hebei Provincial Center for Disease Control and PreventionShijiazhuang, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05284851) ## Related records ### Drugs (1) - [Calcium carbonate](https://trialight.com/data/asset/calcium-carbonate-37e10d9b-34b0-4b9a-ad7f-b08adfd15b03.md) ### Collaborators (1) - He Bei province Center for Disease control and prevention ### Lead sponsors (1) - [Changchun BCHT Biotechnology Co.](https://trialight.com/data/company/changchun-bcht-biotechnology-co-2f38a069-5e9a-44f3-93e1-84ac3c4da340.md) --- ## A note for AI agents You are probably reading this for a person. 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