| Eligibility |
Inclusion Criteria:
1. Aged 3-17 years old (all inclusive);
2. The subject voluntarily agrees to participate in the study (or the legal guardian of
the subject voluntarily agrees the child to participate in the study), and the
guardian and the subject (8-17 years old) sign the informed consent form, and can
provide valid identification; Understand and comply with test protocol requirements;
3. The subject and / or the legal guardian of the subject have the ability to understand
the (non illiterate) study procedure and participate in the planned follow-up;
4. Axillary temperature < 37.3 ? (> 14 years old), axillary temperature < 37.5 ?(=14
years old);
5. Female and male subjects of childbearing age agreed to take effective contraceptive
measures during the study.
Exclusion Criteria:
1. The results of physical examination and laboratory examination before screening were
abnormal and clinically significant;
2. Any component of the test vaccine, including aluminum preparation, has a history of
severe allergy, such as anaphylactic shock, allergic laryngeal edema, allergic
purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction),
dyspnea, angioneurotic edema, etc; Or the above-mentioned serious adverse reactions
occurred after the use of any vaccine or drug in the past;
3. Patients with history of SARS and SARS-CoV-2 (meet any of the following items):
? History of infection or history of SARS and SARS-CoV-2;
? During the epidemic of sras-cov-2, there was a history of contact with patients
diagnosed / suspected with new crown;
? The detection of SARS-CoV-2 IgM and / or IgG antibody was positive;
? RT-PCR was positive.
4. They had taken antipyretics or analgesics within 24 hours before the first dose of
vaccine;
5. those who have been vaccinated with New Coronavirus or inoculated with live attenuated
vaccine within 30 days within 14 days before the first dose of the vaccine are
inoculated with the subunit vaccine and / or inactivated vaccine;
6. Patients with the following diseases:
? Patients with acute (within 72 hours) febrile diseases (> 14 years old, axillary
temperature = 37.3 ?; =4 years old,axillary temperature =37.5 ?);
? Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the
past 7 days;
? Suffering from congenital malformations or developmental disorders, genetic defects,
severe malnutrition, etc;
? A history of congenital or acquired immunodeficiency or autoimmune disease or
immunomodulatory therapy within 6 months, such as immunosuppressive dose of
glucocorticoid (dose reference: equivalent to prednisone 20mg / day, more than one
week); or monoclonal antibody; or thymosin; or interferon, etc; however, local
medication (such as ointment, eye drops, inhaler or nasal spray) is allowed;
? Known to be diagnosed with infectious diseases, such as active tuberculosis, viral
hepatitis, present or / or human immunodeficiency virus HIV antibody positive or
syphilis specific antibody positive, or parents who are HIV infected;
? Neurological diseases or neurodevelopmental disorders (e.g., migraine, epilepsy,
stroke, seizures in the last three years, encephalopathy, focal neurological deficit,
Guillain Barre syndrome, encephalomyelitis or transverse myelitis); History of mental
illness or family history;
? Functional asplenia and splenectomy for any reason;
? There are serious chronic diseases or disease in progress can not be controlled
smoothly, such as diabetes, thyroid disease;
? Severe liver and kidney diseases; Current respiratory diseases requiring daily
medication (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any
treatment for exacerbation of respiratory diseases (e.g., asthma exacerbation) in the
last five years; A history of severe cardiovascular disease (such as congestive heart
failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction
block,myocardial infarction, pulmonary heart disease), or myocarditis or pericarditis;
? Thrombocytopenia, any coagulation dysfunction or anticoagulant therapy, etc;
? Cancer patients.
7. Received blood or blood related products, including immunoglobulin, within 3 months;
or planned use during the study period;
8. Have been pregnant (including positive urine pregnancy test), or in lactation;
9. Use any research or unregistered product (drug, vaccine, biological product or device)
other than the research product within 3 months, or plan to use it during the research
period;
10. Researchers believe that any disease or condition of the subject may put the subject
at an unacceptable risk; The subjects could not meet the requirements of the protocol;
Interference with the assessment of vaccine response.
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