> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-i-ii-clinical-trial-of-26-valent-pneumococcal-1eb00219-a89c-44da-a0ed-144de6051f6b > Record changed: 2026-10-13 # Phase I/II Clinical Trial of 26-valent Pneumococcal Conjugate Vaccine NCT06703203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) Participants 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) Lead sponsor Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) Start date 2025-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## Title and summary **Summary** The purpose of this experiment is to evaluate the safety and immunogenicity of the 26 valent pneumococcal conjugate vaccine in the population aged 2 months and above. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Short title** Phase I/II Clinical Trial of 26-valent Pneumococcal Conjugate Vaccine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Official title** A Single-center, Randomized, Double-blind, Active-controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of 26-valent Pneumococcal Conjugate Vaccine in People Aged 2 Months and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## Dates **Completion date** 2026-02-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **First posted** 2024-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Registry last updated** 2026-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Primary completion date** 2025-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Start date** 2025-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## Size and sites **Actual participants** 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Participants** 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Lead sponsor** Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## Identifiers **Registry ID** NCT06703203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **ClinicalTrials.gov ID** NCT06703203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## 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/NCT06703203) ## Outcomes ### Primary outcomes 1. AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ） Timeframe: 30 day after each vaccination All AE occurrences within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination) 2. Solicited AE occurrences within 0-30 minutes after each dose of vaccination (for phase Ⅰ/Ⅱ） Timeframe: 30 minutes after each vaccination The occurrence of Solicited adverse events (AE) within 0-30 minutes after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination) 3. Solicited AE occurrences within 0-7 days after each dose of vaccination (for phase Ⅰ/Ⅱ） Timeframe: 0-7 days after each vaccination The occurrence of solicited adverse events (AE) within 0-7 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination); 4. Unsolicited AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ） Timeframe: 0-30 days after each vaccination The occurrence of unsolicited adverse events (AE) within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination); 5. Grade 3 and above AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ） Timeframe: 0-30 days after each vaccination The occurrence of grade 3 and above adverse events within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination). 6. All SAE occurrences within 0-6 months after vaccination (for Phase Ⅱ) Timeframe: 0-6 months after each vaccination The occurrence of all serious adverse reactions within 6 months after vaccination (number of cases, incidence rate, and relationship with vaccination) 7. Positive rate of serotype-specific pneumococcal IgG antibody on the 30th day after immunization in subjects aged 2-5 years （for phase Ⅱ） Timeframe: 30 day after vaccination Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 μg/ml on Day 30 after vaccination in subjects aged 2-5 years ### Secondary outcomes 1. All SAE in the population aged ≥12 months during 0-6 months after vaccination （for phase Ⅰ） Timeframe: 0-6 months after vaccination All SAE in the population aged 12 months and older from the first dose to 6 months after the full course of vaccination 2. All SAE in the population aged <12 months from the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster（for phase Ⅰ） Timeframe: From the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster All SAE from the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster in the population less than 12 months of age. 3. Proportion of IgG antibodies ≥ 1.0 µg/mL and GMC results on Day 30 post-immunization（for phase Ⅱ） Timeframe: 30 day after vaccination Proportion of subjects with serotype-specific pneumococcal IgG antibodies ≥ 1.0 µg/mL and GMC results on Day 30 post-immunization in subjects 2 to 5 years of age. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 2 Months **Healthy volunteers** Yes ### Inclusion criteria - The subject is 2-3 months old (minimum 6 weeks old), 7 months old and above at the time of enrollment, and the legal guardian and/or the subject can provide legal identification certificate; - The subjects themselves and/or their legal guardians understand the vaccination and trial procedures, voluntarily participate in the trial and sign the informed consent form; - The subject and/or legal guardian can comply with the clinical trial protocol, have the ability to use thermometer, scale and fill in diary card and contact card as required; - Female subjects of childbearing potential agree to take effective contraceptive measures from enrollment to 6 months after vaccination. - For calibration group subjects: 18 to 55 years of age, ≥ 50 kg for males or ≥ 45 kg for females. ### Exclusion criteria - Axillary body temperature ≥ 37.3 ℃ on the day of enrollment; - History of infectious diseases caused by Streptococcus pneumoniae confirmed by bacterial culture within 3 years; - Have received or plan to receive a Streptococcus pneumoniae vaccine outside the trial protocol, including marketed or other investigational Streptococcus pneumoniae vaccines; - Pregnant or lactating women; Previous history of severe allergy to any vaccine or drug, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock, Henoch-Schonlein purpura, thrombocytopenic purpura; - Allergic to any component of the investigational vaccine; - Suffering from severe respiratory diseases (such as severe asthma), heart diseases, liver diseases, kidney diseases, congenital malformations, developmental disorders and genetic defects (including but not limited to: down syndrome, thalassemia major, etc.) that may interfere with the conduct or completion of the trial; - Diagnosed with congenital or acquired immunodeficiency, or suspected to have serious chronic disease or systemic disease that may interfere with the conduct or completion of the trial, such as: active tuberculosis, human immunodeficiency virus (HIV) infection, etc.; - Encephalopathy, uncontrolled epilepsy, convulsion and other progressive neurological diseases, or a history or family history of mental illness; - Contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy; - Asplenia or splenectomy, functional asplenia due to any condition; - Immunosuppressant therapy, cytotoxic therapy or corticosteroid therapy within 3 months prior to vaccination, such as systemic glucocorticoid therapy for more than 2 consecutive weeks, such as prednisone or similar drugs > 5 mg/day (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-complicated dermatitis); - Received blood products or immunoglobulins within 3 months prior to enrollment (hepatitis B immunoglobulin is acceptable), or planned to be used during the trial (before the last immunogenicity blood sample collection); - Within 3 days before the first dose of vaccine, the patient has acute illness or is in acute attack of chronic disease, or has used antipyretic, analgesic or anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, etc.); - Received non-live vaccine within 7 days (≤ 7 days) or live attenuated vaccine within 14 days (≤ 14 days) prior to enrollment; - Hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, applicable to adults); - Abnormal and clinically significant laboratory test results, which are not suitable for enrollment as determined by the investigator (applicable to subjects aged 2 years and older in Phase I); - Birth weight < 2.5 kg, premature delivery (gestational age < 37 weeks), history of abnormal labor process, history of asphyxia rescue, history of nerve organ damage, history of pathological jaundice confirmed by diagnosis; - For Standardised Subjects: ① Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 50 U/L; Or hemoglobin ≤ 115 g/L (female)/120g/L (male); Any positive serology for hepatitis B, hepatitis C, HIV, or syphilis. - Plans to move before the end of the trial or leave the area for an extended period of time during scheduled trial visits; - Ongoing participation or planning to participate in other clinical trials (vaccines, drugs, medical devices, etc.) in the near future; - Subject has any condition that, in the opinion of the investigator, may interfere with the evaluation of the objectives of the trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## Sites - Henan Provincial Center for Disease Control and PreventionShangqiu, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06703203) ## Related records ### Drugs (1) - [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) - [Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd](https://trialight.com/data/company/beijing-zhifei-lvzhu-biopharmaceutical-co-ltd-ae139965-14e4-4af3-8e90-c5859c2868d7.md) --- ## 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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