Created at Source Raw Value Validated value
Feb. 19, 2021, 12:45 a.m. oms

1. Subjects with axillary body temperature above 37.0 degrees C, 2. Patients with history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (mers), 3. Female subjects with positive urine pregnancy test, or pregnant or lactating women, 4. Subjects with acute sinusitis or acute rhinitis within 3 days before vaccination, or subjects with chronic sinusitis or chronic rhinitis accompanied with acute attack symptoms, 5. Patients with intranasal granuloma, nasal septum deviation, nasal polyps and other abnormal conditions that may affect specimen collection or vaccination judged by clinicians, 6. Subjects who had fever within 3 days before vaccination (axillary temperature >= 38.0 degrees C) or who had any acute disease in the past 5 days and needed systemic application of antibiotics or antiviral drugs (including but not limited to the use of antiviral drugs such as Tamiflu, Relenza, symmetry or flumadine), 7. Subjects with severe chronic medical diseases or whose condition can not be controlled smoothly after using drugs, such as hypertension (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg), diabetes, asthma, thyroid diseases, etc, 8. Patients with immune deficiency diseases, including primary diseases, cancer, immune diseases (including Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, splenectomy or splenectomy caused by any condition, and other immune diseases that researchers think may affect immune response), etc, 9. Subjects who received immunoglobulin and / or blood preparations within 3 months before vaccination, or planned to use them during the study period, 10. Subjects who received subunit or inactivated vaccine within 14 days before vaccination, or who received live attenuated vaccine within 28 days before vaccination, 11. Subjects who have received other research drugs or vaccines within one month before vaccination, or who plan to use other research drugs or vaccines during the research period, 12. Subjects who received any intranasal medication or nasal surgery within 7 days before vaccination, 13. Subjects who used immunosuppressants and other immunomodulatory drugs for a long time (lasting for more than 14 days) within 6 months before vaccination, or systemic use of corticosteroids (local ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included), 14. Subjects with a history of severe allergy, including those who have had severe adverse reactions such as allergy, urticaria, dyspnea, angioneurotic edema, etc., or who are allergic to any component of the vaccine used in this trial, 15. Subjects who had taken or planned to use aspirin, drugs containing aspirin or salicylate within 14 days before vaccination, 16. Subjects who reported coagulation disorders or coagulation dysfunction in the past, 17. After inquiring about the subjects' medical history and related physical examination, the researcher judged that various medical, psychological, social, occupational or other conditions may affect the progress of clinical research.

1. Subjects with axillary body temperature above 37.0 degrees C, 2. Patients with history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (mers), 3. Female subjects with positive urine pregnancy test, or pregnant or lactating women, 4. Subjects with acute sinusitis or acute rhinitis within 3 days before vaccination, or subjects with chronic sinusitis or chronic rhinitis accompanied with acute attack symptoms, 5. Patients with intranasal granuloma, nasal septum deviation, nasal polyps and other abnormal conditions that may affect specimen collection or vaccination judged by clinicians, 6. Subjects who had fever within 3 days before vaccination (axillary temperature >= 38.0 degrees C) or who had any acute disease in the past 5 days and needed systemic application of antibiotics or antiviral drugs (including but not limited to the use of antiviral drugs such as Tamiflu, Relenza, symmetry or flumadine), 7. Subjects with severe chronic medical diseases or whose condition can not be controlled smoothly after using drugs, such as hypertension (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg), diabetes, asthma, thyroid diseases, etc, 8. Patients with immune deficiency diseases, including primary diseases, cancer, immune diseases (including Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, splenectomy or splenectomy caused by any condition, and other immune diseases that researchers think may affect immune response), etc, 9. Subjects who received immunoglobulin and / or blood preparations within 3 months before vaccination, or planned to use them during the study period, 10. Subjects who received subunit or inactivated vaccine within 14 days before vaccination, or who received live attenuated vaccine within 28 days before vaccination, 11. Subjects who have received other research drugs or vaccines within one month before vaccination, or who plan to use other research drugs or vaccines during the research period, 12. Subjects who received any intranasal medication or nasal surgery within 7 days before vaccination, 13. Subjects who used immunosuppressants and other immunomodulatory drugs for a long time (lasting for more than 14 days) within 6 months before vaccination, or systemic use of corticosteroids (local ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included), 14. Subjects with a history of severe allergy, including those who have had severe adverse reactions such as allergy, urticaria, dyspnea, angioneurotic edema, etc., or who are allergic to any component of the vaccine used in this trial, 15. Subjects who had taken or planned to use aspirin, drugs containing aspirin or salicylate within 14 days before vaccination, 16. Subjects who reported coagulation disorders or coagulation dysfunction in the past, 17. After inquiring about the subjects' medical history and related physical examination, the researcher judged that various medical, psychological, social, occupational or other conditions may affect the progress of clinical research.

Nov. 12, 2020, 11:45 p.m. oms

1) Axillary temperature>37.0 degree C, 2) Those with a history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), 3) Women with a positive urine pregnancy test, or women in pregnancy or lactation period, 4) Subjects suffering from acute sinusitis, acute rhinitis, or chronic sinusitis or chronic rhinitis with acute exacerbation symptoms within 3 days before vaccination, 5) Abnormalities in the nasal cavity, such as granulomas in the nasal cavity, deviation of the nasal septum, and nasal polyps, which may affect specimen collection or vaccination according to the clinician's judgment, 6) Those who had fever (axillary temperature >=38.0 degree C) within 3 days before vaccination or had any acute disease in the past 5 days and needed systemic antibiotic or antiviral treatment (including but not limited to the use of oseltamiflu (Tamiflu), Namivir (Relenza), amantadine (Symmetrel) or rimantadine (Flumadine) and other anti-influenza virus drugs), 7) People who suffer from severe chronic medical diseases or whose condition cannot be controlled smoothly after using drugs, such as hypertension (systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmHg), diabetes, asthma, thyroid disease, etc., 8) People with immunodeficiency diseases, primary diseases of important organs, cancer, immune diseases (including Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, asthenia or splenectomy due to any condition and other immune diseases that researchers believe may have an impact on the immune response), etc., 9) Received immunoglobulin and/or blood preparations within 3 months before vaccination, or plan to use them during the study period, 10) Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination, 11) Those who have received other research drugs or vaccines within 1 month before vaccination, or plan to use other research drugs or vaccines during the study period, 12) Have received any intranasal drug treatment or nasal surgery within 7 days before vaccination, 13) Long-term use of immunosuppressants and other immunomodulatory drugs, or systemic use of corticosteroid drugs (topical ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included) within 6 months before vaccination, 14) People who have a history of severe allergies, including those who have had serious adverse reactions from previous vaccination, such as allergies, urticaria, dyspnea, angioedema, etc., or allergic to any component of the vaccine used in this study, 15) Those who have taken aspirin, drugs containing aspirin or salicylate within 14 days before vaccination or planned to use them in this study, 16) those who reported having coagulation disorder or abnormal coagulation function in the past, 17) The investigator judged after inquiring the subject's medical history and related physical examinations that various medical, psychological, social conditions, occupational factors, or other conditions may affect the conduct of clinical research.

1) Axillary temperature>37.0 degree C, 2) Those with a history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), 3) Women with a positive urine pregnancy test, or women in pregnancy or lactation period, 4) Subjects suffering from acute sinusitis, acute rhinitis, or chronic sinusitis or chronic rhinitis with acute exacerbation symptoms within 3 days before vaccination, 5) Abnormalities in the nasal cavity, such as granulomas in the nasal cavity, deviation of the nasal septum, and nasal polyps, which may affect specimen collection or vaccination according to the clinician's judgment, 6) Those who had fever (axillary temperature >=38.0 degree C) within 3 days before vaccination or had any acute disease in the past 5 days and needed systemic antibiotic or antiviral treatment (including but not limited to the use of oseltamiflu (Tamiflu), Namivir (Relenza), amantadine (Symmetrel) or rimantadine (Flumadine) and other anti-influenza virus drugs), 7) People who suffer from severe chronic medical diseases or whose condition cannot be controlled smoothly after using drugs, such as hypertension (systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmHg), diabetes, asthma, thyroid disease, etc., 8) People with immunodeficiency diseases, primary diseases of important organs, cancer, immune diseases (including Guillain Barre syndrome, systemic lupus erythematosus, rheumatoid arthritis, asthenia or splenectomy due to any condition and other immune diseases that researchers believe may have an impact on the immune response), etc., 9) Received immunoglobulin and/or blood preparations within 3 months before vaccination, or plan to use them during the study period, 10) Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination, 11) Those who have received other research drugs or vaccines within 1 month before vaccination, or plan to use other research drugs or vaccines during the study period, 12) Have received any intranasal drug treatment or nasal surgery within 7 days before vaccination, 13) Long-term use of immunosuppressants and other immunomodulatory drugs, or systemic use of corticosteroid drugs (topical ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included) within 6 months before vaccination, 14) People who have a history of severe allergies, including those who have had serious adverse reactions from previous vaccination, such as allergies, urticaria, dyspnea, angioedema, etc., or allergic to any component of the vaccine used in this study, 15) Those who have taken aspirin, drugs containing aspirin or salicylate within 14 days before vaccination or planned to use them in this study, 16) those who reported having coagulation disorder or abnormal coagulation function in the past, 17) The investigator judged after inquiring the subject's medical history and related physical examinations that various medical, psychological, social conditions, occupational factors, or other conditions may affect the conduct of clinical research.