Diseases caused by the new coronavirus
Conditions
Interventions
Experimental group1:COVID-19 Vaccine+23-valent pneumonia vaccine+Quadrivalent influenza vaccine
Control group:COVID-19 Vaccine
Experimental group2:23-valent pneumonia vaccine+Quadrivalent influenza vaccine
Sponsors
Hubei Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years on the day of enrollment; 2. The subject signed the informed consent and signed the date; 3. The subject is able to participate in all planned follow-up visits and is able to comply with all study procedures (e.g., complete diary cards, return for visits); 4. The subjects have not been vaccinated with any pneumonia vaccine, new crown vaccine and have not been vaccinated with the current season influenza vaccine before enrollment; 5. The time interval between the subject and the last vaccination is >=14 days; 6. Qualified medical history and clinical examination, and axillary temperature <37.3 centigrade before entering this study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have previously been infected with new coronary pneumonia or who have been positive for nucleic acid testing; 2. Those with a history or family history of allergies, convulsions, epilepsy, encephalopathy and mental illness; 3. Those who are allergic to any component of the vaccine, and those who have a history of severe allergy to any previous vaccination; 4. Those who suffer from immunodeficiency, during the treatment of malignant tumors, receive immunosuppressive therapy (oral steroid hormones) or immunocompromised caused by HIV, or those who have congenital immune diseases in close contact with family members; 5. Injection of non-specific immunoglobulin within 1 month before enrollment; 6. Those suffering from acute febrile diseases and infectious diseases; 7. Those with a history of definite diagnosis of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection; 8. For patients with severe chronic diseases or acute exacerbations of chronic diseases, through lifestyle adjustment and (or) drug treatment, those with systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmH on the day of vaccination, through lifestyle adjustment and (or) drug treatment, Those whose fasting blood glucose is still >13.9 mmol/L on the day of vaccination, who are in the period of acute complications of diabetes (ketoacidosis, hyperosmolar state, lactic acidosis), or those who have recovered from the above complications within 2 weeks; 9. Various infectious, purulent and allergic skin diseases; 10. Women who are pregnant or breastfeeding, those who plan to give birth within 3 months after vaccination, please suspend vaccination; 11. Any situation that the investigator believes may affect the evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive conversion rate and antibody level;The occurrence of adverse events within 30 minutes after each dose;Occurrence of adverse events 0-28 days after each dose;Occurrence of adverse event within 6 months after full immunization; | — |
Countries
China
Contacts
Public ContactZhang Xianfeng
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed