> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/clinical-trial-of-13-valent-pneumococcal-conjugate-vaccine-ff5fbd30-86ca-4d6e-aa54-cdbc5f89b3f8 > Record changed: 2026-10-13 # Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine NCT06617715 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) Participants 3,080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) Lead sponsor Sinovac Life Sciences Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) Start date 2024-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) ## Title and summary **Summary** A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Short title** Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Official title** A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) ## Dates **Completion date** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **First posted** 2024-09-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Registry last updated** 2026-01-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Primary completion date** 2026-05-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Start date** 2024-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) ## Size and sites **Participants** 3,080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Planned participants** 3,080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Lead sponsor** Sinovac Life Sciences Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) ## Identifiers **Registry ID** NCT06617715 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **ClinicalTrials.gov ID** NCT06617715 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) ## 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/NCT06617715) ## Outcomes ### Primary outcomes 1. Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) Timeframe: 30 days after primary vaccination Proportion of serotype-specific IgG concentration ≥0.35 μg/ml 2. Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) Timeframe: 30 days after primary vaccination IgG GMC ### Secondary outcomes 1. Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) Timeframe: 30 days after booster vaccination Proportion of serotype-specific IgG concentration ≥0.35 μg/ml 2. Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) Timeframe: 30 days after booster vaccination IgG GMC 3. Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8 Timeframe: 30 days after primary vaccination Proportion of participants with pneumococcal serotype-specific OPA antibody titers ≥ 1:8 4. Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT) Timeframe: 30 days after primary vaccination Pneumococcal serotype-specific OPA antibody GMT 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. Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) Timeframe: 30 days after primary vaccination Pneumococcal serotype-specific IgG GMI 7. Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI) Timeframe: 30 days after primary vaccination Pneumococcal serotype-specific OPA antibody GMI 8. Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL Timeframe: 30 days after booster vaccination Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL 9. Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) Timeframe: 30 days after booster vaccination Pneumococcal serotype-specific IgG GMI 10. Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate) Timeframe: 30 days after booster vaccination Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate) 11. Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT) Timeframe: 30 days after booster vaccination Pneumococcal serotype-specific OPA antibody GMT 12. Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI) Timeframe: 30 days after booster vaccination Pneumococcal serotype-specific OPA antibody GMI 13. Safety of Sinovac PCV13 Timeframe: 0-30 days within each dose Incidence of adverse reactions 14. Safety of Sinovac PCV13 Timeframe: 6 months within final dose Incidence of serious adverse events Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Weeks **Maximum age** 5 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy infants or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday); 2. Participants' guardians provide legal identity document and participants' vaccination record; 3. Participants' guardians understand and voluntarily sign the informed consent form; 4. Participants' guardians can follow all study procedures and stay in contact during the study. ### Exclusion criteria 1. Received any pneumococcal vaccine prior to enrollment; 2. History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests; 3. History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain; 4. History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age; 5. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma; 6. Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation); 7. Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignant tumours. 8. Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases. 9. History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomy caused by any reasons; 10. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture. 11. Consecutively received ≥14 days of corticosteroid, any other immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or cytotoxic therapy prior to enrollment for infants aged 6 weeks to 2 months or within 6 months prior to enrollment for children aged 7 months to 5 years. 12. Received blood products prior to enrollment for children aged 2 months or within 3 months prior to enrollment for children aged 7 months to 5 years. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception. 13. Received other investigational drugs within 60 days prior to enrollment, or plan to receive such drugs during the study; 14. Received live attenuated vaccine within 14 days prior to enrollment; 15. Received subunit or inactivated or other vaccine within 7 days prior to enrollment; 16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment; 17. Had fever (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/NCT06617715) ## Sites - Henan Provincial Center for Disease Control and PreventionZhengzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06617715) ## Related records ### Drugs (2) - [Rotigaptide](https://trialight.com/data/asset/rotigaptide-bb594923-f30b-49ff-a57b-b85c7e052627.md) - [Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae CRM197](https://trialight.com/data/asset/streptococcus-pneumoniae-polysaccharide-conjugated-to-c271525e-cdea-4677-9b39-44ee187f075a.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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