Tick-borne encephalitis
Conditions
Interventions
Study group:0,14 days, inoculate 2 doses of TBEV, and 1 booster dose 12 months after the first dose of immunization
1.0ml per dose
Influenza control group:0 day, inoculate 1 dose of IIV4
0.5ml per dose
Sponsors
Center for Comprehensive Disease Control and Prevention of Inner Mongolia Autonomous Region
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The target population is over 8 years old on the day of enrollment; 2. The legal guardian of volunteers under the age of 18 has signed the informed consent form; 3. Subjects were able to participate in all planned visits and to follow all study procedures; 4. The subjects had not been vaccinated with tick-borne encephalitis vaccine; 5. Axillary body temperature <= 37.0 degree.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for first dose inoculation: Volunteers shall check the following criteria before entering the group. If any of the following criteria exists, they shall not participate in this study: (1) Used any investigational or unregistered product (drug, vaccine or device) within 30 days before enrollment, or planned to be used during the study; (2) Have received tick-borne encephalitis vaccine (registered or research) before enrollment, or plan to use it during the study; (3) Long-term use of immunosuppressants or other immunomodulatory drugs (defined as continuous use for more than 14 days) within 3 months before enrollment, such as glucocorticoid dose of 0.5mg/kg/day (inhalation and local steroid hormones are not limited); (4) Use of immunoglobulins and/or any blood products within 3 months before enrollment, or planned for use during the study (before post-immunization blood sample collection); (5) The interval before vaccination was less than 7 days in the other attenuated groups; (6) Any known or suspected allergy to any component of tick-borne encephalitis vaccine (including excipients, formaldehyde, kanamycin sulfate, bovine serum albumin, etc.); Or having a history of severe allergic reactions after previous vaccination (including anaphylactic shock, allergic laryngeal edema, allergic purpura and local allergic necrosis); (7) Any known or suspected allergy to any component (including egg protein) or ingredient of influenza vaccine; Have a history of allergic reaction when eating eggs, or have a history of severe allergic reaction after previous vaccination (including allergic shock, allergic laryngeal edema, allergic purpura and local allergic necrosis); A history of Guillain Barre syndrome after previous influenza vaccination; (8) Suffering from acute disease, serious chronic disease, acute attack of chronic disease, epilepsy, other nervous system diseases, allergic diseases or history of allergy to biological products; (9) Acute disease/infection (according to the judgment of the investigator) or fever (axillary temperature > 37.0 degree) on the day of vaccination; (10) Any obvious abnormal coagulation function or history of anticoagulant therapy; (11) Any confirmed or suspected immunosuppressive or immunodeficiency disease; (12) Have congenital heart disease or other congenital defects that are not suitable for vaccination; (13) Currently suffering from respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver, kidney diseases, mental abnormalities, or chronic infection and other diseases; (14) During pregnancy or lactation; (15) Those who are clinically diagnosed with forest encephalitis or have a history of forest encephalitis; (16) According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial. 2. Exclusion criteria for second dose inoculation: (1) New discovery or new occurrence meeting the first exclusion criteria before vaccination (vaccination can be postponed if it meets Articles 5 and 8 of the exclusion criteria). (2) Severe allergic reaction at the first dose of inoculation; (3) Serious adverse events related to the previous vaccination; 3. Booster immunization exclusion criteria: Volunteers should check the following criteria before strengthening immunization. If any of the following criteria exist, they cannot participate in this study: (1) Any investigational or unr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralization Antibody level;Seropositivity;Seroconversion rate; | — |
Countries
China
Contacts
Public ContactYan Shaohong
Center for Disease Control and prevention of Inner Mongolia Autonomous Region
Outcome results
None listed