a study of booster immunization with covid-19 vaccine,inactivated co -administration with influenza vaccine and pneumococcal polysaccharide vaccine

Conditions: COVID-19

Summary: this study is a single center , randomized ,controlled and open-label phase ⅳclinical trial of the booster immunization with the third dose of inactivated covid-19 vaccine(coronavac)manufactured by sinovac research \& development co.,ltd. the purpose of this study is to evaluate the immunogenicity and safety of the third dose of covid-19 vaccine,inactivated (vero cell) co-administration with influenza vaccine and pneumococcal polysaccharide vaccine in healthy population aged 18 years and older.

this study is a single center , randomized ,controlled and open-label phase ⅳclinical trial in healthy adult aged 18 years and older. the purpose of this study is to evaluate the immunogenicity and safety of the third dose of covid-19 vaccine,inactivated (vero cell) co-administration with influenza vaccine and pneumococcal polysaccharide vaccine.the covid-19 vaccine was manufactured by sinovac research \&development co., ltd,and the quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine(ppv23) were manufactured by sinovac biotech co.a total of 3000 subjects will be enrolled, with 300 aged 18\~59years(adult group) and 300 aged 60 years and above(adult group) in the section of immunogenicity and safety of combined immunization ,with 1200 aged 18\~59 years(adult group) and 1200 aged 60 years and above(elderly group) in the section of safety observation study of combined immunization.each age group will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of covid-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine in the section of immunogenicity and safety of combined immunization and each age group will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of covid-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine in the section of safety observation study of combined immunization.

Eligibility criteria:
inclusion criteria: * healthy adults aged 18 years and above; * have been received two doses of inactivated sars-cov-2 vaccine(coronavac)manufactured by sinovac research \& development co., ltd at an interval of 6 months or more; * participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ; * proven legal identity; exclusion criteria: * history of sars-cov-2 infection; * have been received two doses of inactivated sars-cov-2 vaccine(coronavac)manufactured by sinovac research \& development co., ltd at an interval of less than 6 months; * have received received any circulating seasonal influenza vaccine; * have received any pneumococcal vaccine within 5 years; * history of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; * history of uncontrolled epilepsy and other serious neurological diseases such as transverse myelitis, guillain-barre syndrome, demyelinating diseases; * history of fever at the time of vaccination, or acute onset of chronic disease, or severe uncontrolled chronic disease, or acute disease; * already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months; * receipt of other investigational drugs in the past 30 days; * receipt of attenuated live vaccines in the past 14 days; * receipt of inactivated or subunit vaccines in the past 7 days; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.