COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05480436

Tao Huang

ymlc01@hncdc.com

2022-07-29

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria 1 : participants were hemodialysis patients aged ≥18 years. the duration of dialysis of the participants was ≥3 months. the life expectancy of participants was ≥2 years. participants who have not previously been infected with sars-cov-2. participants had not received any covid-19 vaccine and had not received any influenza or pneumonia vaccine within 1 year. for female participants of reproductive age, they had no fertility plan within the first 3 months and had taken effective contraceptive measures within 2 weeks ; for male participants of reproductive age, no fertility plans were made within 3 months. be able and willing to complete the entire study plan during the study follow-up period. have the ability to understand the study procedures, voluntarily sign informed consent. inclusion criteria 2 : body temperature < 37.3 °c confirmed by clinical examination before enrollment . systolic blood pressure (sbp) was < 160 mmhg and diastolic blood pressure (dbp) was< 100 mmhg , and fasting blood glucose (fpg) was ≤13.9 mmol/l on the day of enrollment. female participants of reproductive age were not pregnant. exclusion criteria 1 for the first dose: being allergic to any component of vaccines and a history of severe allergic reactions to any vaccine or allergic to pollen, food and other common allergens, or a history of allergic reaction to eating eggs or using gentamicin sulfate. participants with uncontrolled epilepsy or a history or family history of epilepsy, a history of guillain-barre syndrome, reye syndrome, and other progressive diseases. participants were confirmed to be infected with h1n1, h3n2, by and bv influenza viruses within 6 months. pregnant and lactating women. participants were in the period of acute illness or acute onset of chronic disease, and the acute complication has been cured for less than two weeks. participants with acute febrile diseases and infectious diseases (including hepatitis b, hepatitis c, hiv patients and carriers, as well as patients with suspected pulmonary tuberculosis symptoms such as hemoptysis, night sweats and weight loss). participants with congenital immunodeficiency or currently receiving immunosuppressive therapy (oral steroid hormones, calcineurin inhibitors (cnis), rituximab, long-term glucocorticoid use ≥1 week). participants injected with non-specific immunoglobulin within 30 days. participants received attenuated vaccines within 30 days and inactivated or other vaccines within 14 days. serious drug adverse reactions and drug-related complications occurred during dialysis treatment. participants with severe cardiovascular diseases (e.g., myocardial infarction, heart failure, malignant arrhythmia). participants with infectious, suppurative and allergic skin diseases or severe skin itching (refers to the widespread and persistent attack; affecting self-regulated activities of daily living or sleep; systemic glucocorticoid or immunosuppressive therapy is required). participants with malignant tumors. participants had a history of seizures, encephalopathy, or psychiatric disorders (depressive mania, depression, schizophrenia, etc.). other participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies. exclusion criteria 2 for the first dose: participants who need medical intervention (except blood glucose) after laboratory tests (blood routine, blood biochemical, coagulation routine) are judged by the investigator. participants had a history of clearly diagnosed thrombocytopenia or other coagulation disorders, which may be contraindicated as subcutaneous injections the participant did not inform the investigator in time of any condition mentioned in " exclusion criteria 1 for the first dose ". other participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies. exclusion criteria for the second dose: subjects who had vaccine-related serious adverse reactions after vaccination. high fever (axillary temperature > 40.0℃) lasted for two days after vaccination, or severe allergic reaction occurred. any vaccine-related neurological adverse reactions occurred after vaccination. participants experienced new conditions that met the "exclusion criteria for the first dose ". other reasons for exclusion considered by the investigator.

None

3

China National Biotec Group Company Limited

18

100

China

High risk patients

N/A

1200

Hemmagglution inhibition antibody GMI against IIV4;Hemmagglution inhibition antibody GMT against IIV4;IgG antibody GMC against PPV23;IgG antibody GMI against PPV23;Neutralizing antibody geometric mean increase (GMI) against SARS-CoV-2;Neutralizing antibody GMT against SARS-CoV-2;Seroconversion rate against IIV4;Seroconversion rate against PPV23;Seroconversion rate against SARS-CoV-2

None

Phase 4

[{"arm_notes": "nan", "treatment_id": 2576, "treatment_name": "Bbibp-corv+pneumococcal vaccine+quadrivalent inactivated influenza vaccine", "treatment_type": "Inactivated virus+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "nan", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2220, "treatment_name": "Pneumococcal vaccine+quadrivalent inactivated influenza vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]