Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT05499351
Brief Summary:
This study is a single center , randomized ,controlled and open-label phase â…£clinical 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.
Detailed Description:
This study is a single center , randomized ,controlled and open-label phase â…£clinical 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.
Study:
NCT05499351
Study Brief:
Protocol Section:
NCT05499351