Diseases caused by the novel coronavirus infection
Conditions
Interventions
Intervention group:The intervention group was inoculated with Influenza Virus Vector COVID-19 Vaccine for Intranasal Spray
Control group:blank
Sponsors
Yancheng Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) At the time of enrollment, the age was = 18 years old. 2) Able and willing to comply with the requirements of the research protocol and sign an informed consent form. 3) Those who are healthy or have underlying chronic diseases but are in a stable state (those who have stable drug control or volunteers who have not been hospitalized or changed in treatment measures due to this disease within the past two months, as determined by the researchers and recorded). 4) It is 3 months or more from the previous COVID-19 infection (or never infected), and 6 months or more from the previous COVID-19 vaccine immunization interval.
Exclusion criteria
Exclusion criteria: 1) At the time of enrollment, there were suspected symptoms of acute COVID-19/influenza, such as dry throat, sore throat, cough, etc. 2) Fever, axillary temperature>37.0 ?. 3) Individuals with a history of severe allergies (such as acute allergic reactions, angioneurotic edema, breathing difficulties, etc.) or known or suspected to have a history of severe allergies to the research vaccine and one of its components. 4) Pregnant or lactating women. 5) HIV infection, tuberculosis, immune deficiency caused by illness or long-term medication use. 6) Uncontrolled epilepsy and other progressive nervous system disease (such as transverse myelitis, Guillain Barre syndrome, demyelinating diseases, etc. 7) According to the judgment of the investigator, volunteers are not suitable for other situations in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of COVID-19 endpoint cases at least 14 days (= 15 days) after vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of severe and above COVID-19 endpoint cases at least 14 days (= 15 days) after vaccination;Serious adverse events (SAE) throughout the entire study period (approximately 6 months after enrollment); | — |
Countries
China
Contacts
Public ContactZhang Hongjun
Yancheng Center for Disease Prevention and Control
Outcome results
None listed