A Study of Booster Immunization With COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Adult group in immunogenicity and safety study of combined immunization; Biological: Elderly group in immunogenicity and safety study of combined immunization; Biological: Adult group in safety observation study of combined immunization; Biological: Elderly group in safety observation study of combined immunization

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.

• Study Type: Interventional
• Enrollment (Actual): 3000
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100013
    • Beijing Centers for Diseases Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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: Adult group in immunogenicity and safety 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.
EXPERIMENTAL: Elderly 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; 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.
EXPERIMENTAL: 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: Adult 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.
EXPERIMENTAL: Elderly 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days after the booster immunization with the third dose of COVID-19 vaccine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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	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	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	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	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	28 days after single and combined vaccination

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2021
• Primary Completion (ACTUAL): December 5, 2021
• Study Completion (ACTUAL): May 5, 2022

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (ACTUAL): August 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRO-nCOV-MA4005-BJ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No