Study Results
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Basic Information
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COMPLETED
PHASE1
170 participants
INTERVENTIONAL
2024-06-21
2025-02-26
Brief Summary
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Detailed Description
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A total of at least 168 participants will be enrolled, including 84 adults aged 18-59 years and 84 elderly people aged ≥60 years. Participants will be randomized in a 2:2:2:1 ratio to receive one dose of PCV24 formulation 1, PCV24 formulation 2, Pneumovax® or placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Experimental: Sinovac PCV24 formulation 1
48 participants will be randomized to receive Sinovac PCV24 formulation 1. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.
Sinovac PCV24 formulation 1
One dose of Sinovac PCV24 formulation 1（0.5mL）
Experimental: Sinovac PCV24 formulation 2
48 participants will be randomized to receive Sinovac PCV24 formulation 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.
Sinovac PCV24 formulation 2
One dose of Sinovac PCV24 formulation 2（0.5mL）
Active control: Pneumovax®
48 participants will be randomized to receive Pneumovax®. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.
Pneumovax®
One dose of Pneumovax® (0.5 mL) contains 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F saccharides.
Placebo: Normal saline
24 participants will be randomized to receive placebo. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose.
Placebo
0.5 mL of 0.9%NaCl solution (normal saline)
Interventions
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Sinovac PCV24 formulation 1
One dose of Sinovac PCV24 formulation 1（0.5mL）
Sinovac PCV24 formulation 2
One dose of Sinovac PCV24 formulation 2（0.5mL）
Pneumovax®
One dose of Pneumovax® (0.5 mL) contains 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F saccharides.
Placebo
0.5 mL of 0.9%NaCl solution (normal saline)
Eligibility Criteria
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Inclusion Criteria
2. Participants understand and voluntarily sign the informed consent form;
3. Participants can follow all study procedures and stay in contact during the study.
Exclusion Criteria
2. History of invasive pneumococcal diseases (IPDs) or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
3. History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock;
4. Congenital malformations or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
5. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, such as hypertension uncontrolled by drugs (measurement on site: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) and coronary heart disease, metabolic diseases (such as uncontrolled diabetes), hematological diseases (e.g. severe anemia, hemophilia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
6. Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection)
7. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
8. Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
9. Long-term alcohol or drug abuse.
10. Have received \> 14 days of immunosuppressive or other immunomodulatory therapy (such as prednisone ≥20 mg/ day, or its equivalent) in the past 6 months, or cytotoxic therapy, or plan to receive such therapy during the study period.
11. Received immunoglobulin or other blood products within 3 months prior to enrollment, or plan to receive such treatment during the study period;
12. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
13. Received live attenuated vaccine within 14 days prior to enrollment;
14. Received subunit or inactivated or other vaccine within 7 days prior to enrollment;
15. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, or known or suspected active infection;
16. Women who are breastfeeding;
17. Fertile women aged 18-59 years who plan to become pregnant or cannot use effective contraception or have egg donation plans from enrollment to 3 months after the study intervention;
18. Women who are pregnant (as judged by the participant's blood pregnancy test);
19. Had fever (axillary temperature\> 37.0℃) before vaccination;
20. Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant.
21. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.
18 Years
ALL
Yes
Sponsors
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Sinovac Life Sciences Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kai Chu
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine)
Locations
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Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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PRO-PCV24-1001
Identifier Type: -
Identifier Source: org_study_id
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