> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/clinical-trial-of-pcv24-in-infants-aged-2-23-months-7d7ed396-5c16-45c2-9905-e5a39606d28a > Record changed: 2026-10-13 # Clinical Trial of PCV24 in Infants Aged 2-23 Months NCT06800261 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) Participants 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) Lead sponsor Sinovac Life Sciences Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) Start date 2025-05-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## Title and summary **Summary** A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months. 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Short title** Clinical Trial of PCV24 in Infants Aged 2-23 Months Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Official title** A Randomized, Double-blind, Positive Controlled Phase Ib Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2 (Minimum 42 Days)-23 Months Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## Dates **Completion date** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **First posted** 2025-01-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Registry last updated** 2026-01-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Primary completion date** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Start date** 2025-05-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## Size and sites **Participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Planned participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Lead sponsor** Sinovac Life Sciences Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## Identifiers **Registry ID** NCT06800261 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **ClinicalTrials.gov ID** NCT06800261 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## 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/NCT06800261) ## Outcomes ### Primary outcomes 1. Incidence of adverse reactions Timeframe: 0-30 days after vaccination Incidence of adverse reactions within 30 days after vaccination ### Secondary outcomes 1. Incidence of adverse reactions Timeframe: 0-7 days after vaccination Incidence of adverse reactions within 7 days after vaccination 2. Incidence of serious adverse events (SAE) Timeframe: from vaccination to 6 months after final dose Incidence of SAE during the period of safety monitoring 3. Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) Timeframe: 30 days after primary vaccination IgG GMC 30 days after primary vaccination 4. Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) Timeframe: 30 days after primary vaccination IgG GMI 30 days after primary vaccination 5. Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL Timeframe: 30 days after primary vaccination Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL 6. Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate) Timeframe: 30 days after primary vaccination Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 42 Days **Maximum age** 23 Months **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months; 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 1. Received any pneumococcal vaccine prior to enrollment; 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). 10. Have/have suffered from a serious neurological disorder (epilepsy or convulsions, but febrile convulsion is not an exclusion criteria ) or mental illness or have a family history of such diseases. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## Sites - Shandong Provincial Center for Disease Control and PreventionJinan, ChinaNot yet recruiting - Shanxian Center for Disease Control and PreventionShancheng, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06800261) ## Related records ### Drugs (1) - [Rotigaptide](https://trialight.com/data/asset/rotigaptide-bb594923-f30b-49ff-a57b-b85c7e052627.md) ### Lead sponsors (1) - [Sinovac Life Sciences Co., Ltd.](https://trialight.com/data/company/sinovac-life-sciences-co-ltd-d3dbe3ae-1264-4328-a691-a71dbc1efbbc.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. 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