> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-ii-clinical-trial-of-24-valent-pneumococcal-a20e8fe2-b3a1-4362-9202-34c6735fe07b > Record changed: 2026-10-13 # Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine NCT06678620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) Participants 992 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) Lead sponsor Reinovax Biologics Co., LTD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) Start date 2024-04-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) ## Title and summary **Summary** A phase II clinical trial of a 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 study's objective is to evaluate the safety and immunogenicity of PCV24\. The trial is a single-center, randomized, blinded, parallel-controlled, non-inferiority design II clinical trial. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Short title** Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Official title** A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) ## Dates **Completion date** 2024-12-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **First posted** 2024-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Registry last updated** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Primary completion date** 2024-12-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Start date** 2024-04-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) ## Size and sites **Actual participants** 992 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Participants** 992 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Lead sponsor** Reinovax Biologics Co., LTD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) ## Identifiers **Registry ID** NCT06678620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **ClinicalTrials.gov ID** NCT06678620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) ## 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/NCT06678620) ## Outcomes ### Primary 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. Positive conversion rate of specific IgG antibodies by serotype Timeframe: 0\~30 days after vaccination The positive conversion rate of IgG antibody of each serotype covered by pneumococcal vaccine detected by Enzyme linked immunosorbent assay (ELISA) 30 days after immunization in each group. ### Secondary outcomes 1. The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus Timeframe: 0\~30 days after vaccination The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus in subjects 30 days after immunization in each group Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Volunteers aged 18 and above 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 vaccination with pneumococcal conjugate vaccine, prior vaccination with pneumococcal polysaccharide vaccine for less than 3 years, or previous history of invasive disease caused by Streptococcus pneumoniae; 2. 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.; 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 prior to vaccination); 4. 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); 5. Those who have acute febrile illness or acute infectious disease or have cold symptoms, advanced influenza and take medication; 6. History of nervous system damage, severe congenital malformations, severe developmental disorders, 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 the disease is in the advanced stage and cannot be controlled smoothly; 11. Have received blood or blood-related products or immunoglobulins within 3 months; 12. Received live attenuated vaccine within 14 days; 13. Other vaccinations 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. 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/NCT06678620) ## Sites - Pizhou Center for Disease Control and PreventionPizhou, China - Xuzhou Center for Disease Control and PreventionXuzhou, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06678620) ## Related records ### Drugs (2) - [Clofarabine](https://trialight.com/data/asset/clofarabine-df6136eb-4ce5-4462-8034-d6d6374f0221.md) - [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 ### Targets (14) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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