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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Influenza and Pneumonia

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined immunization group<br>160 subjects received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0. | Biological: Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine<br>* Quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine were manufactured by Sinovac Biotech Co., Ltd.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.<br>|
| Experimental: Non combined immunization group<br>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. | Biological: Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine<br>* Quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine were manufactured by Sinovac Biotech Co., Ltd.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0 and one dose of 23-valent pneumococcal polysaccharide vaccine on day 28 in subgroup 1,and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of quadrivalent influenza vaccine on day 28 in subgroup 2.<br>|
| Experimental: Safety group<br>2520 subjects were enrolled and received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0. | Biological: Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine<br>* Quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine were manufactured by Sinovac Biotech Co., Ltd.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies | GMT of influenza HI antibodies for each influenza strain at 28 days after combined vaccination . | 28 days after combined vaccination | 

Secondary Outcome Measures

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