A Phase 4 interventional study of Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine and Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in Influenza and Pneumonia, sponsored by Sinovac Biotech Co., Ltd. Completed at 4 sites in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by Sinovac Biotech Co., Ltd · Phase 4, Interventional, and Prevention
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.
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 3,000 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Sinovac Biotech Co., Ltd is the lead sponsor of 89 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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
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
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
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.
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.
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 .
Time frame: 28 days after combined vaccination
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Sinovac Biotech Co., Ltd