Diseases caused by the novel coronavirus infection
Conditions
Interventions
Experimental group:Test vaccines are administered at days 0 and 14
Control group:Placebo was given at days 0 and 14
Sponsors
Jiangsu Provincial Center For Disease Control and Prevention (Public Health Research Institute of Jiangsu Province)
Eligibility
Sex/Gender
All
Age
3 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Aged 3~17 years old at the time of signing the informed consent form; 2. Subjects/guardians are able to comply with the requirements of the clinical research protocol to complete all trial procedures and sign the informed consent form. (for subjects under 8 years of age, the informed consent form should be signed by their guardians; for subjects over 8 years of age, the informed acceptance form and informed consent form should be signed by subjects themselves and their guardians, respectively); 3. No history of COVID-19; 4. Have not been vaccinated with any COVID-19 vaccine, or subjects who have not received any COVID-19 vaccine within 6 months prior to the date when sign the informed consent for this study.
Exclusion criteria
Exclusion criteria: 1. No nucleic acid polymerase chain reaction (RT-PCR) test results or test results were positive for SARS-CoV-2 within 48 hours. 2. Axillary temperature > 37.0 ?; 3. Before immunization, blood routine and blood biochemical laboratory collected abnormal indicators of which severity reached grade 2 or above; 4. Have a history of severe allergies, including those who known or suspected history of allergic to any component of the vaccine used in this trial, or severe allergies from previous immunizations, or subject is of allergic constitution. 5. Those who have severe chronic medical diseases or conditions that cannot be controlled with medication steadily, including but not limited to congenital or acquired heart disorders, asthma, immunodeficiency diseases, immune disorders, cancer, etc.. 6. Those who had fever (axillary temperature >=38.0 ?) within 3 days before vaccination or 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 anti influenza virus drugs such as Tamiflu, Relenza, Symmetrel or flumadine); 7. Long-term (lasting more than 14 days) use of immunosuppressants and other immunoregulatory drugs or systemic use of corticosteroids (Topical ointment, eye drops, inhalers, etc. are allowed, but nasal spray is not included ) within 6 months before vaccination; 8. Received immunoglobulin and/or blood preparations within 3 months before vaccination, or plan to use them during the study period; 9. Received any intranasal medication or nasal surgery within 7 days before vaccination; 10. History of a major surgery within 3 months prior to enrolment, or have major surgery planned during the study, or have undergone surgery that affected the results of the trial; 11. Those who have taken aspirin, drugs containing aspirin or salicylate within 14 days before vaccination or plan to use them within 30 days after vaccination; 12. Received subunit or inactivated vaccine within 14 days before vaccination, or received live attenuated vaccine within 28 days before vaccination; 13. Those who have received other research drugs or vaccines within one month before vaccination, or plan to use other research drugs or vaccines during the research period; 14. History of hemorrhagic diseases (e.g., factor deficiency, thrombocytopenia or other coagulation disorders), or hemorrhagic tendency, or continuous requirement of anticoagulants; 15. History of fainting during a blood collection or needle insertion procedure, or poor venous conditions (a history of difficult blood collection or corresponding symptoms or signs, cannot tolerate venipuncture); 16. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All solicited adverse events occurring within 7 days after each dose of vaccination;All unsolicited adverse events occurring within 30 days after each dose of vaccination;Serious adverse events that occur throughout the observation period (from the first vaccination to 12 months after the last vaccination).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in laboratory parameters before and 48 hours after vaccination with each dose (blood routine, blood biochemistry);Subjects' nasopharyngeal swab (12-17 years old) or oropharyngeal swab (3-11 years old) viral shedding level of vaccine strain (RNA content); | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Provincial Center For Disease Control and Prevention (Public Health Research Institute of Jiangsu Province)
Outcome results
None listed