To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations.
After giving informed consent, patients with hypertension, patients with diabetes, patients with both diseases, and healthy controls, all aged 60 years or older, were given two doses of the inactivated SARS-CoV-2 vaccine (Vero cells). Venous blood samples were collected before the first dose and on day 28 after the second dose to evaluate the immunogenicity of the vaccine. Adverse events were actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the first dose and the second dose. Within 3 months after immunization with the second dose and collection of diary cards, the subjects were followed up by phone once a month as well as self-report to collect serious adverse events.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,440
2 doses of Covid-19 vaccine
Nan'an Center for Disease Control and Prevention
Quanzhou, Fujian, China
Songtao Miao Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou, China
You County Center for Disease Control and Prevention
Zhuzhou, Hunan, China
Seroconversion rate
the rate of positive seroconversion against coronavirus
Time frame: Up to 28 days after the second dose
Neutralizing antibody level
neutralizing antibody level against coronavirus
Time frame: Up to 28 days after the second dose
Adverse events following vaccination
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Time frame: up to 6 months
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