Study on Combined Vaccination With Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine

Immunogenicity and Safety of Quadrivalent Influenza Vaccine Combined Immunization With 23-valent Pneumococcal Polysaccharide Vaccine in the Elderly Aged 60 Years and Above

NCT05471531•Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

This study is an open-label,single center phase Ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.The purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in the elderly aged 60 years and above.

Detailed Description

This study is an open-label,single center,phase IV clinical trial in the elderly aged 60 Years and above.The experimental vaccines were manufactured by Sinovac Biotech Co., Ltd. A total of 3000 subjects will be enrolled,the safety and immunogenicity of combined immunization were evaluated in 480 subjects,and the Safety observation of combined immunization was evaluated in the extended safety group, which included 2520 subjects.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•The elderly aged 60 and above;
•The subjects and/or guardians can understand and voluntarily sign the informed consent form;
•Proven legal identity.

Exclusion Criteria

•Received any circulating seasonal influenza vaccine prior to enrollment;
•Have received any pneumococcal vaccine within 5 years;
•History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
•History of uncontrolled epilepsy and other serious neurological disorders (e.g.transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.)
•Fever,acute onset of chronic disease,severe uncontrolled chronic disease or acute disease at the time of vaccination;
•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.

Locations (4)

Jingjiang Center for Diseases Control and Prevention

Taizhou, Jiangsu, China

Taizhou City Hospital of Traditional Chinese and Western Medicine

Taizhou, Jiangsu, China

Gaogang District Center for Disease Control and Prevention

Taizhou, Jiangsu, China

Xinghua Center for Disease Control and Prevention

Taizhou, Jiangsu, China

Key Dates

Start Date

November 13, 2021

Primary Completion Date

March 10, 2022

Completion Date

July 10, 2022

Last Updated

July 25, 2022

Enrollment

3,000

ACTUAL participants

Conditions

Influenza and Pneumonia

Interventions

Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine

BIOLOGICAL

Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine

BIOLOGICAL