COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04790851

Xiaodong Sun

sunxiaodong@scdc.sh.cn

2021-03-10

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - ≥18 years old when enrolled; - participants signing the informed consent; - being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview; - 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; - ≥14 days from the most recent vaccination; - before enrollment, the body temperature is ≤37.0c as confirmed by medical history and clinical examination. exclusion criteria for the first dose: - having a history of covid-19 or a positive nucleic acid test for covid-19; - having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness; - being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine; - 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; - having injection of non-specific immunoglobulin within 1 month prior to enrollment; - having acute febrile illness or communicable disease; - having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection; - having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes; - having various infectious, pyogenic, or allergic skin diseases; - women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination; - having any condition that may affect trial assessment as determined by researchers. exclusion criteria for the second dose: - having any serious adverse event related to the first dose vaccination; - after vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers; - having a newly emerging condition that meets the exclusion criteria for the first dose; - having any condition that may affect trial assessment as determined by researchers.

None

3

China National Biotec Group Company Limited

18

100

China

Healthy volunteers

N/A

1133

Hemmagglution inhibition antibody level (IIV4);Hemmagglution inhibition antibody level (IIV4);Hemmagglution inhibition antibody level (IIV4);Neutralizing antibody level (COVAX);Neutralizing antibody level (COVAX);Neutralizing antibody level (COVAX);Neutralizing antibody level (PPV23);Neutralizing antibody level (PPV23);Neutralizing antibody level (PPV23);Seroconversion rate (COVAX);Seroconversion rate (COVAX);Seroconversion rate (IIV4);Seroconversion rate (IIV4);Seroconversion rate (PPV23);Seroconversion rate (PPV23);Seropositive rate (IIV4)

None

Phase 4

[{"arm_notes": "2;1st dose: Inactivated SARS-CoV-2 Vaccines (Vero Cell)+IIV4, 2nd dose: Inactivated SARS-CoV-2 Vaccines (Vero Cell)+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", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;1st dose: IIV4, 2nd dose: PPV23", "treatment_id": 2220, "treatment_name": "Pneumococcal vaccine+quadrivalent inactivated influenza vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]