Status:
UNKNOWN
To Explore a Bridging Index for the Effectiveness of the Clinical Trial
Lead Sponsor:
Changchun BCHT Biotechnology Co.
Conditions:
Randomized
Eligibility:
All Genders
3-59 years
Phase:
NA
Brief Summary
To explore a bridging index for the effectiveness of the clinical trial with Nasal Spray Lyophilized Live Attenuated Influenza Vaccine
Detailed Description
With a randomized, blind, parallel placebo-controlled design, to screen the susceptible individuals aged 3\~59 years old whose titers of either of Hi antibody level of H1N1, H3N2 or B are not higher t...
Eligibility Criteria
Inclusion
- healthy volunteer aged 3\~59 years old；
- no vaccination with any influenza vaccine within the past year；
- no catching any influenza or flu like symptoms （axillary temperature ≥ 38℃， accompanied by cough or sore throat ）；
- influenza susceptible individual（any serum Hi antibody level of H1N1, H3N2 and B≦1:10）；
- with informed consent obtained from the volunteer and / or guardian；
- willing of volunteers and / or guardians to comply with the requirements of the clinical trial protocol.
Exclusion
- Known allergy individual to any ingredient of this product, including egg protein, subsidiary material and/or gentamycin sulfate;
- patients with acute disease, severe chronic disease, acute attack of chronic disease and/or fever (axillary temperature ≥ 37.3℃ on the day of immunisation);
- pregnancy (enquire);
- patients with Leigh syndrome treated with aspirin or aspirin containing drugs;
- patients with immunodeficiency or receiving immunosuppressive therapy;
- patients with uncontrolled epilepsy and other progressive nervous system diseases, with a history of Guillain Barre syndrome;
- patients with rhinitis or other nasal abnormalities judged by clinicians that may affect vaccination or sample collection;
- accept any immunoglobulin and / or any blood products within 3 months, or plan to use them during the study (until post immunization blood sample collection);
- .taking anti influenza drugs in the past 48 hours;
- .any situation that the researchers believe may affect the study.
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 25 2022
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04825340
Start Date
April 16 2021
End Date
March 25 2022
Last Update
April 13 2021
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