Clinical trial NCT05471531: Study on Combined Vaccination With Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine
Official title: Immunogenicity and Safety of Quadrivalent Influenza Vaccine Combined Immunization With 23-valent Pneumococcal Polysaccharide Vaccine in the Elderly Aged 60 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza and Pneumonia
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-07-25
Enrollment: 3000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: 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.

Primary outcomes:
measure: Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies
timeFrame: 28 days after combined vaccination
Secondary outcomes:
measure: Immunogenicity index of the seroconversion rates of influenza HI antibodies
timeFrame: 28 days after combined vaccination
measure: Immunogenicity index of Geometric Mean Increase (GMI) of influenza HI antibodies
timeFrame: 28 days after combined vaccination
measure: Immunogenicity index of seropositivity rates of influenza HI antibodies
timeFrame: 28 days after combined vaccination
measure: Immunogenicity index of Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
timeFrame: 28 days after combined vaccination
measure: Immunogenicity index-seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
timeFrame: 28 days after combined vaccination
measure: Immunogenicity index-GMI for 23 serotypes specificity of pneumococcal IgG antibody
timeFrame: 28 days after combined vaccination
measure: Geometric mean titer(GMT) of influenza HI antibodies
timeFrame: 28 days after a single injection of quadrivalent influenza vaccine
measure: Seroconversion rates of influenza HI antibodies
timeFrame: 28 days after a single injection of quadrivalent influenza vaccine
measure: Geometric Mean Increase (GMI) of influenza HI antibodies
timeFrame: 28 days after a single injection of quadrivalent influenza vaccine
measure: Seropositivity rates of influenza HI antibodies
timeFrame: 28 days after a single injection of quadrivalent influenza vaccine
measure: Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
timeFrame: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
measure: Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
timeFrame: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
measure: GMI for 23 serotypes specificity of pneumococcal IgG antibody
timeFrame: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
measure: Safety index-incidence of adverse reactions
timeFrame: Within 7 days after combined immunization
measure: Safety index-Incidence of adverse reactions
timeFrame: Within 28 days after combined immunization
measure: Incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
timeFrame: Within 7 days after a single injection of quadrivalent influenza vaccine
measure: The incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
timeFrame: Within 28 days after a single injection of quadrivalent influenza vaccine
measure: Incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine
timeFrame: Within 7 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
measure: The incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine
timeFrame: Within 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Jingjiang Center for Diseases Control and Prevention
state: Jiangsu
city: Taizhou
country: China
facility: Taizhou City Hospital of Traditional Chinese and Western Medicine
state: Jiangsu
city: Taizhou
country: China
facility: Gaogang District Center for Disease Control and Prevention
state: Jiangsu
city: Taizhou
country: China
facility: Xinghua Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Taizhou Center for Disease Control and Prevention
name: Zhongkui Zhu, Master
role: PRINCIPAL_INVESTIGATOR
References: