A Phase 4 interventional study of Adult group in immunogenicity and safety study of combined immunization and Elderly group in immunogenicity and safety study of combined immunization in COVID-19, sponsored by Sinovac Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by Sinovac Biotech Co., Ltd · Phase 4, Interventional, and Prevention
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.
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This study's enrollment of 3,000 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
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300 participants 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
Biological: Adult group in immunogenicity and safety study of combined immunization
300 participants 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
Biological: Elderly group in immunogenicity and safety study of combined immunization
1200 participants 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
Biological: Adult group in safety observation study of combined immunization
1200 participants 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
Biological: Elderly group in safety observation study of combined immunization
The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
The COVID-19 vaccine was manufactured by Sinovac Research \& Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
Immunogenicity index of seroconversion rate of the neutralizing antibody
Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the booster immunization with the third single dose of COVID-19 vaccine
Time frame: 28 days after the booster immunization with the third dose of COVID-19 vaccine
Immunogenicity index of seropositivity rate of the neutralizing antibody
Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization
Time frame: 28 days after combined immunization
Immunogenicity index of GMT of the neutralizing antibody
GMT of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization
Time frame: 28 days after combined immunization
Immunogenicity index of GMI of the neutralizing antibody
GMI of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization.
Time frame: 28 days after combined immunization
Immunogenicity index of seroconversion rate of 23 pneumonia antibodies
Seroconversion rate of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine.
Time frame: 28 days after single and combined vaccination of 23 valent pneumonia vaccine
Immunogenicity index of GMC increase of 23 pneumonia antibodies
GMC increase of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine
Time frame: 28 days after single and combined vaccination of 23 valent pneumonia vaccine
Immunogenicity index of seroconversion rate of 4 influenza antibodies
Seroconversion rate of 4 influenza antibodies 28 days after single and combined vaccination
Time frame: 28 days after single and combined vaccination
Immunogenicity index of GMT of 4 influenza antibodies
GMT of 4 influenza antibodies 28 days after single and combined vaccination
Time frame: 28 days after single and combined vaccination
Immunogenicity index of GMI of 4 influenza antibodies
GMI of 4 influenza antibodies 28 days after single and combined vaccination
Time frame: 28 days after single and combined vaccination
Immunogenicity index of protection rate of 4 influenza antibodies
Protection rate of 4 influenza antibodies 28 days after single and combined vaccination
Time frame: 28 days after single and combined vaccination
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Sinovac Biotech Co., Ltd