The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine
NCT ID: NCT05284851
Last Updated: 2022-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
2520 participants
INTERVENTIONAL
2022-04-01
2022-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental group 1
Healthy people in experimental group will receive a dose of Live Attenuated Influenza Vaccine (non freeze- dried)
Live 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.
Positive control group
Healthy people in Positive control group will receive a dose of Live Attenuated Influenza Vaccine ( freeze- dried)
Live Attenuated Influenza Vaccine(freeze-dried)
Live Attenuated Influenza Vaccine Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
Placebo group
Healthy people in placebo group will receive a dose of placebo
Live Attenuated Influenza Vaccine placebo
Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.
Interventions
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Live 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.
Live 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
Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
59 Years
ALL
Yes
Sponsors
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He Bei province Center for Disease control and prevention
UNKNOWN
Changchun BCHT Biotechnology Co.
INDUSTRY
Responsible Party
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Locations
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Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Countries
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Other Identifiers
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Bchtpharm
Identifier Type: -
Identifier Source: org_study_id
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