Immunogenicity and Safety of Inactivated COVID-19 Vaccine Coadministered With 23-valent Pneumococcal Polysaccharide Vaccine and Quadrivalent Influenza Vaccine in Hemodialysis Population: a Multicentre, Randomised, Controlled, Phase 4 Trial
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population.
• 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.
• 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.