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This study is an open-label,single center phase â…£ 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined immunization group | Experimental | 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 | Experimental | 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 | Experimental | 2520 subjects were enrolled and received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine | Biological | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhongkui Zhu, Master | Taizhou Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jingjiang Center for Diseases Control and Prevention | Taizhou | Jiangsu | 214527 | China | ||
| Taizhou City Hospital of Traditional Chinese and Western Medicine |
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| Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine | Biological | 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. |
|
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 |
| Taizhou |
| Jiangsu |
| 225309 |
| China |
| Gaogang District Center for Disease Control and Prevention | Taizhou | Jiangsu | 225323 | China |
| Xinghua Center for Disease Control and Prevention | Taizhou | Jiangsu | 225799 | China |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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