> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-i-clinical-trial-of-pcv24-in-people-aged-18-years-and-57e72d45-78aa-431c-8c18-48f7bca43893 > Record changed: 2026-10-13 # Phase I Clinical Trial of PCV24 in People Aged 18 Years and Older NCT06678607 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) Lead sponsor Reinovax Biologics Co., LTD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) Start date 2023-11-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Title and summary **Summary** Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older . The objective of the study is to evaluate the safety and tolerability of PCV24\. The trial is a single-center, randomized, blind,parallel-controlled design I clinical trial. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Short title** Phase I Clinical Trial of PCV24 in People Aged 18 Years and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Official title** Phase I Clinical Trial to Evaluate the Safety and Tolerability of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Dates **Completion date** 2024-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **First posted** 2024-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Registry last updated** 2024-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Primary completion date** 2024-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Start date** 2023-11-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Size and sites **Actual participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Lead sponsor** Reinovax Biologics Co., LTD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Identifiers **Registry ID** NCT06678607 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **ClinicalTrials.gov ID** NCT06678607 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Outcomes ### Primary outcomes 1. Incidence of adverse reactions Timeframe: 0-7days after vaccination Incidence of adverse reactions within 7 days after vaccination ### Secondary outcomes 1. incidence of adverse events Timeframe: 0\~30 days after vaccination. The incidence of adverse events within 30 days after vaccination. 2. Incidence of serious adverse events (SAE) Timeframe: 0-6 months after vaccination Incidence of SAE during the period of safety monitoring 3. Incidence of clinically significant abnormality in laboratory examination tests Timeframe: 0-3days after vaccination Incidence of clinically significant abnormality in blood routine, blood biochemistry,coagulation function and urine routine test results within 3 days after vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Volunteers over the age of 18 on the day of screening, and can provide legal identification; 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 1. Previous pneumococcal vaccination, or history of invasive disease caused by pneumococcal in the past; 2. Have any previous history of severe allergies to vaccines or drugs, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Athus reaction), etc.; 3. 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 before vaccination (Note: the use of topical and inhaled/nebulized steroids can participate); 4. Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (when measured on site: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥100 mmHg), etc.; 5. Suffering from acute febrile illness or infectious diseases, such as tuberculosis, viral hepatitis, etc.; 6. History of nervous system damage, severe congenital malformations, severe developmental disabilities, severe genetic defects, severe malnutrition, etc.; 7. Have a history or family history of epilepsy, encephalopathy, or psychiatric disorders; 8. 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; 9. asplenia, functional asplenia, and asplenia or splenectomy due to any cause; 10. Suffering from severe chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes, thyroid disease, etc.; 11. Have received blood or blood-related products or immunoglobulins within 3 months; 12. Received live attenuated vaccine within 14 days; 13. Received other vaccines within 7 days; 14. Received other investigational drugs or vaccines within 1 month; 15. Is participating in or plans to participate in clinical studies of other drugs or vaccines during the study period; 16. Any other condition that, in the opinion of the investigator, may interfere with the study evaluation; 17. Those who have abnormal laboratory tests such as blood routine, blood biochemistry, and urine routine that are clinically significant and cannot be enrolled according to the comprehensive judgment of the investigator; 18. Exclusion Criteria for Partial Populations: Females of childbearing potential (18\~49 years old): positive urine pregnancy test on the day of enrollment, lactation, or pregnancy plans within 6 months. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Sites - Zhenjiang Center for Disease Control and PreventionZhenjiang, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678607) ## Related records ### Drugs (1) - [Insulin efsitora alfa](https://trialight.com/data/asset/insulin-efsitora-alfa-9de5c01f-5ba8-4897-93f1-75044083ba25.md) ### Lead sponsors (1) - [Reinovax Biologics Co., LTD](https://trialight.com/data/company/reinovax-biologics-co-ltd-18348a14-7004-42c2-9436-5fc7f3c06f52.md) ### Conditions (1) - [Pneumococcal infection](https://trialight.com/data/condition/pneumococcal-infection-b3a7fc66-25ac-57f8-8fb4-073403fe8b1b.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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