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

Phase 4

Completed

• Conditions: Influenza and Pneumonia
• Interventions: Biological: 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

• Registration Number: NCT05471531
• Lead Sponsor: Sinovac Biotech Co., Ltd

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.

Study Timeline

• Study Start: 2021-11-13
• Primary Completion: 2022-03-10
• Status Verified: 2022-07
• Study Completion: 2022-07-10
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-25
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined immunization group	Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine	160 subjects received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.
Non combined immunization group	Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine	There were two subgroups in non combined immunization group,and 160 subjects in each subgroup.The non combined immunization subgroup 1 received one dose of quadrivalent influenza vaccine on day 0 and one dose of 23-valent pneumococcal polysaccharide vaccine on day 28.The non combined immunization subgroup 2 received one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of quadrivalent influenza vaccine on day 28.
Safety group	Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine	2520 subjects were enrolled and received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.

Primary Outcome Measures

Name	Time	Method
Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies	28 days after combined vaccination	GMT of influenza HI antibodies for each influenza strain at 28 days after combined vaccination .

Secondary Outcome Measures

Name	Time	Method
Safety index-incidence of adverse reactions	Within 7 days after combined immunization	Incidence of adverse reactions at 0\~7 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.
Safety index-Incidence of adverse reactions	Within 28 days after combined immunization	Incidence of adverse reactions at 0\~28 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.
Immunogenicity index of seropositivity rates of influenza HI antibodies	28 days after combined vaccination	Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Immunogenicity index-GMI for 23 serotypes specificity of pneumococcal IgG antibody	28 days after combined vaccination	GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Geometric mean titer(GMT) of influenza HI antibodies	28 days after a single injection of quadrivalent influenza vaccine	GMT of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
The incidence of adverse reactions after a single injection of quadrivalent influenza vaccine	Within 28 days after a single injection of quadrivalent influenza vaccine	Incidence of adverse reactions at 0\~28 after a single injection of quadrivalent influenza vaccine.
The incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine	Within 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine	Incidence of adverse reactions at 0\~28 after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Immunogenicity index of Geometric Mean Increase (GMI) of influenza HI antibodies	28 days after combined vaccination	GMI of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Immunogenicity index of Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody	28 days after combined vaccination	GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Immunogenicity index-seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody	28 days after combined vaccination	Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody	28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine	Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Immunogenicity index of the seroconversion rates of influenza HI antibodies	28 days after combined vaccination	Seroconversion rate of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Incidence of adverse reactions after a single injection of quadrivalent influenza vaccine	Within 7 days after a single injection of quadrivalent influenza vaccine	Incidence of adverse reactions at 0\~7 after a single injection of quadrivalent influenza vaccine.
Seroconversion rates of influenza HI antibodies	28 days after a single injection of quadrivalent influenza vaccine	Seroconversion rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Geometric Mean Increase (GMI) of influenza HI antibodies	28 days after a single injection of quadrivalent influenza vaccine	GMI of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Seropositivity rates of influenza HI antibodies	28 days after a single injection of quadrivalent influenza vaccine	Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody	28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine	GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
GMI for 23 serotypes specificity of pneumococcal IgG antibody	28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine	GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine	Within 7 days after a single injection of 23-valent pneumococcal polysaccharide vaccine	Incidence of adverse reactions at 0\~7 after a single injection of 23-valent pneumococcal polysaccharide vaccine.

Trial Locations

Locations (4)

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

Jingjiang Center for Diseases Control and Prevention; 🇨🇳 Taizhou, Jiangsu, China