Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine
NCT ID: NCT06678620
Last Updated: 2025-12-17
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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ACTIVE_NOT_RECRUITING
PHASE2
992 participants
INTERVENTIONAL
2024-04-20
2026-03-31
Brief Summary
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Detailed Description
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At least 992 participants will be enrolled, including 496 adults aged 18-60 and 496 elderly people aged ≥61. Participants will be randomized 1:1:1:1 to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PCV24 formulation 3,or PPSV23.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Experimental group 1
248 participants will be randomized to receive Reinovax PCV24 formulation 1. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.
Reinovax PCV24 formulation 1
One dose of Reinovax PCV24 formulation 1（0.5mL）
Experimental group 2
248 participants will be randomized to receive Reinovax PCV24 formulation 2. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.
Reinovax PCV24 formulation 2
One dose of Reinovax PCV24 formulation 1（0.5mL）
Experimental group 3
248 participants will be randomized to receive Reinovax PCV24 formulation 3. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.
Reinovax PCV24 formulation 3
One dose of Reinovax PCV24 formulation 1（0.5mL）
Active control group
248 participants will be randomized to receive PPSV23. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.
PPSV23
One dose of PPSV23 (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 and33F saccharides.
Interventions
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Reinovax PCV24 formulation 1
One dose of Reinovax PCV24 formulation 1（0.5mL）
Reinovax PCV24 formulation 2
One dose of Reinovax PCV24 formulation 1（0.5mL）
Reinovax PCV24 formulation 3
One dose of Reinovax PCV24 formulation 1（0.5mL）
PPSV23
One dose of PPSV23 (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 and33F saccharides.
Eligibility Criteria
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Inclusion Criteria
2. Informed consent must be obtained from the volunteer and signed informed consent form;
3. Volunteers are able and willing to comply with the requirements of the clinical trial protocol and can attend all visits;
4. Armpit body temperature ≤ 37.0 °C on the day of enrollment.
Exclusion Criteria
6. Have any history of severe allergies in the past, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Athus reaction), etc.;
7. Have been diagnosed with congenital or acquired immunodeficiency, or have recently received immunosuppressant therapy, such as systemic glucocorticoid therapy such as prednisone or similar drugs \>5 mg/day for more than 2 consecutive weeks in 1 month prior to vaccination);
8. Suffering from more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg when measured on site);
9. Those who have acute febrile illness or acute infectious disease or have cold symptoms, advanced influenza and take medication;
10. History of nervous system damage, severe congenital malformations, severe developmental disorders, severe genetic defects, severe malnutrition, etc.;
11. Have a history or family history of epilepsy, encephalopathy, or psychiatric disorders;
12. Those who have been diagnosed with thrombocytopenia, any abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities, etc.) or contraindications to intramuscular injection such as anticoagulant therapy;
13. asplenia, functional asplenia, and asplenia or splenectomy due to any cause;
14. Suffering from severe chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly;
15. Have received blood or blood-related products or immunoglobulins within 3 months;
16. Received live attenuated vaccine within 14 days;
17. Other vaccinations within 7 days;
18. Received other investigational drugs or vaccines within 1 month;
19. Is participating in or plans to participate in clinical studies of other drugs or vaccines during the study period;
20. Any other condition that, in the opinion of the investigator, may interfere with the study evaluation;
Females of childbearing potential (18\~49 years old): positive urine pregnancy test on the day of enrollment, lactation, or pregnancy plans within 6 months.
18 Years
ALL
Yes
Sponsors
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Shanghai Reinovax Biologics Co.,LTD
INDUSTRY
Responsible Party
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Locations
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Pizhou Center for Disease Control and Prevention
Pizhou, Jiangsu, China
Xuzhou Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Countries
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Other Identifiers
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JSVCT183
Identifier Type: -
Identifier Source: org_study_id