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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RECRUITING
PHASE1
180 participants
INTERVENTIONAL
2025-05-08
2026-06-30
Brief Summary
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The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase Ib clinical trial.
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Detailed Description
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A total of at least 180 participants aged 2 months (minimum 42 days)-23 months will be enrolled. Participants will be randomized in 1:1 ratio to the test group and control group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Active Comparator: Prevnar®
Participants aged 2 months (minimum 42 days)-23 months will receive Prevnar 13® according to different immunization schedules. Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.
Prevnar®
Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.
Experimental: Sinovac PCV24
Participants aged 2 months (minimum 42 days)-23 months will receive Sinovac PCV24 according to different immunization schedules. Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.
Sinovac PCV24
Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.
Interventions
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Sinovac PCV24
Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.
Prevnar®
Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.
Eligibility Criteria
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Inclusion Criteria
2. Participants' guardian provides legal identity document and participants' vaccination record;
3. Participants' guardian understands and voluntarily signs the informed consent form;
4. Follow all study procedures and stay in contact during the study.
Exclusion Criteria
2. History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;
3. History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;
4. Low birth weight (\<2.5kg), or premature infant (gestation weeks \< 37 weeks) (applies to infants younger than 12 months);
5. History of abnormal labor during delivery (planned cesarean section is excluded), history of asphyxia rescue and nervous system damage (applies to infants younger than 12 months);
6. Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
7. Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases (e.g. congenital heart disease), hematological diseases (e.g. severe anemia), liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
8. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
9. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), potential bleeding (history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture).
11. Consecutively received immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or other immunoregulatory therapies, or cytotoxic therapy over 14 days within 6 months before vaccination, or plans to receive such therapies during the study.
12. Received blood products prior to enrollment within 3 months prior to enrollment, or plans to receive such therapies during the study. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
13. Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study;
14. Received live attenuated vaccine within 14 days prior to enrollment;
15. Received subunit or inactivated vaccine within 7 days prior to enrollment;
16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, known or potentially active infection;
17. Axillary temperature≥ 37.3 Degree Celsius before vaccination;
18. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.
42 Days
23 Months
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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Qing Xu
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincial Center for Disease Control and Prevention
Locations
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Shandong Provincial Center for Disease Control and Prevention
Jinan, Shandong, China
Shanxian Center for Disease Control and Prevention
Shancheng, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Shanxian Center for Disease Control and Prevention
Role: primary
Other Identifiers
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PRO-PCV24-1003
Identifier Type: -
Identifier Source: org_study_id
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