COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=126385

Xianfeng Zhang

739425754@qq.com

2021-05-11

Recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Prevention

1. Aged >=18 years when enrolled, 2. Participants signing the informed consent, 3. Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview, 4. Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment, 5. >=14 days from the most recent vaccination, 6. Before enrollment, the body temperature < 37.3 degree C as confirmed by medical history and clinical examination.

1. Having a history of COVID-19 or a positive nucleic acid test for COVID-19, 2. Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness, 3. Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine, 4. Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder, 5. Having injection of non-specific immunoglobulin within 1 month prior to enrollment, 6. Having acute febrile illness or communicable disease, 7. Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection, 8. Having severe chronic disease or acute exacerbation of chronic disease.Through lifestyle adjustment and/or drug therapy, those with systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmH on the day of vaccination, and those with lifestyle adjustment and/or drug therapy, those whose fasting blood glucose is still >13.9 mmol/L on the day of vaccination , In the period of acute complications of diabetes (ketoacidosis, hypertonic state, lactic acidosis), or those who have recovered from the above complications for less than 2 weeks, 9. Having various infectious, pyogenic, or allergic skin diseases, 10. Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination, 11. Having any condition that may affect trial assessment as determined by researchers.

3

Hubei Provincial Center for Disease Control and Prevention

18

100

China

Healthy volunteers

N/A

1404

Antibody positive rate;Seroconversion rate;Neutralizing antibody level;

| Declared number of arm (6.0) differs from found arms (7.0)

Phase 4

[{"arm_notes": "2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Dose 1: COVIV+PPV23, Dose 2: COVIV+IIV4", "treatment_id": 2219, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)+pneumococcal vaccine+quadrivalent inactivated influenza vaccine", "treatment_type": "Inactivated virus+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "2;Dose 1: PPV23, Dose 2: IIV4", "treatment_id": 2220, "treatment_name": "Pneumococcal vaccine+quadrivalent inactivated influenza vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]