COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=126277

Xiaodong Sun

sunxiaodong@scdc.sh.cn

2021-05-08

Not recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Prevention

1. Aged >=18 years old 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 <=37.0 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, or having uncontrolled hypertension or diabetes, 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

Shanghai Municipal Center for Disease Control and Prevention

18

100

China

Healthy volunteers

N/A

1152

Seroconversion rate;Antibody positive 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+IIV4, Dose 2: COVIV+PPV23", "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: IIV4, Dose 2: PPV23", "treatment_id": 2220, "treatment_name": "Pneumococcal vaccine+quadrivalent inactivated influenza vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]