Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine
NCT ID: NCT05477693
Last Updated: 2023-09-18
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
1800 participants
INTERVENTIONAL
2022-10-25
2023-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental Group
1200 participants(including 600 subjects aged 2\~17 years,240 subjects aged 18\~59 years and 360 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd
Experimental 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
600 participants(including 300 subjects aged 2\~17 years,120 subjects aged 18\~59 years and 180 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Merck Sharp \& Dohme.
Control 23-valent PPV
The control vaccine was manufactured by Merck Sharp \& Dohme, Ltd. Purified capsular polysaccharides from 23 Streptococcus in 0.5 mL of pneumoniae types 0.25% phenol and sodium chloride.
Interventions
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Experimental 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 Merck Sharp \& Dohme, Ltd. Purified capsular polysaccharides from 23 Streptococcus in 0.5 mL of pneumoniae types 0.25% phenol and sodium chloride.
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.If the subject aged 16 to 17 years with full capacity for civil conduct and his/her labor income is his/her main source of living, the informed consent can be signed only by the subject himself/herself);
* Proven legal identity.
Exclusion Criteria
* History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture.
* Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
* History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
* Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
* A long history of alcohol or drug abuse;
* Receipt of blood products within in the past 3 months;
* Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
* Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days;
* Receipt of inactivated or subunit vaccines in the past 7 days;
* Onset of various acute or chronic diseases within 3 days prior to the study;
* Underarm body temperature before vaccination\>37.0°C;
* The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials within 1 months;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
2 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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Weijun Hu
Role: PRINCIPAL_INVESTIGATOR
Shanxi Provincial Center for Disease Prevention and Control
Locations
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Linwei District Center for Disease Control and Prevention
Weinan, Shanxi, China
Countries
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Other Identifiers
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PRO-PPV-4002
Identifier Type: -
Identifier Source: org_study_id
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