Clinical trial NCT05499351: A Study of Booster Immunization With COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine
Official title: A Single Center, Randomized ,Controlled and Open Clinical Trial to Evaluate the Immunogenicity and Safety of the Booster Immunization With the Third Dose of COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-12
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Immunogenicity index of seroconversion rate of the neutralizing antibody
timeFrame: 28 days after the booster immunization with the third dose of COVID-19 vaccine
Secondary outcomes:
measure: Immunogenicity index of seropositivity rate of the neutralizing antibody
timeFrame: 28 days after combined immunization
measure: Immunogenicity index of GMT of the neutralizing antibody
timeFrame: 28 days after combined immunization
measure: Immunogenicity index of GMI of the neutralizing antibody
timeFrame: 28 days after combined immunization
measure: Immunogenicity index of seroconversion rate of 23 pneumonia antibodies
timeFrame: 28 days after single and combined vaccination of 23 valent pneumonia vaccine
measure: Immunogenicity index of GMC increase of 23 pneumonia antibodies
timeFrame: 28 days after single and combined vaccination of 23 valent pneumonia vaccine
measure: Immunogenicity index of seroconversion rate of 4 influenza antibodies
timeFrame: 28 days after single and combined vaccination
measure: Immunogenicity index of GMT of 4 influenza antibodies
timeFrame: 28 days after single and combined vaccination
measure: Immunogenicity index of GMI of 4 influenza antibodies
timeFrame: 28 days after single and combined vaccination
measure: Immunogenicity index of protection rate of 4 influenza antibodies
timeFrame: 28 days after single and combined vaccination
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Centers for Diseases Control and Prevention
Study officials:
affiliation: Beijing Center for Disease Control and Prevention
name: Jiang Wu, Master
role: PRINCIPAL_INVESTIGATOR
References: