A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine
NCT ID: NCT04989465
Last Updated: 2022-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
600 participants
INTERVENTIONAL
2021-09-10
2021-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental Group
450 Participants (including 150 subjects aged 2\~17 years, 150 subjects aged18\~60 years and 150 subjects aged 61years and older ) received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd will be collected venous blood about 3.0\~3.5 ml.
Investigational 23-valent PPV
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection
Control Group
150 Participants (including 50 subjects aged 2\~17 years, 50 subjects aged18\~60 years and 50 subjects aged 61years and older ) received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Chengdu Institute of Biological Products will be collected venous blood about 3.0\~3.5 ml.
Control 23-valent PPV
The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd. 25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of light disodium phenol phosphate, sodium hydrogen phosphate and sodium chloride per injection
Interventions
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Investigational 23-valent PPV
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection
Control 23-valent PPV
The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd. 25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of light disodium phenol phosphate, sodium hydrogen phosphate and sodium chloride per injection
Eligibility Criteria
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Inclusion Criteria
* The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form);
* Proven legal identity.
Exclusion Criteria
* History of invasive disease caused by streptococcus pneumoniae after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine;
* Autoimmune disease or immunodeficiency / immunosuppression was known after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine;
* History of immunosuppressive therapy after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
2 Years
110 Years
ALL
Yes
Sponsors
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Sinovac Biotech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Lili Huang, Master
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial Center for Disease Prevention and Control
Locations
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Kaifeng County Center for Disease Control and Prevention
Kaifeng, Henan, China
Countries
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Other Identifiers
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PRO-PPV-4001
Identifier Type: -
Identifier Source: org_study_id
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