Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-02 @ 9:43 AM
Study NCT ID:
NCT06703203
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-27
First Post:
2024-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Clinical Trial of 26-valent Pneumococcal Conjugate Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）', 'timeFrame': '30 day after each vaccination', 'description': 'All AE occurrences within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination)'}, {'measure': 'Solicited AE occurrences within 0-30 minutes after each dose of vaccination (for phase Ⅰ/Ⅱ）', 'timeFrame': '30 minutes after each vaccination', 'description': '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)'}, {'measure': 'Solicited AE occurrences within 0-7 days after each dose of vaccination (for phase Ⅰ/Ⅱ）', 'timeFrame': '0-7 days after each vaccination', 'description': '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);'}, {'measure': 'Unsolicited AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）', 'timeFrame': '0-30 days after each vaccination', 'description': '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);'}, {'measure': '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', 'description': '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).'}, {'measure': 'All SAE occurrences within 0-6 months after vaccination (for Phase Ⅱ)', 'timeFrame': '0-6 months after each vaccination', 'description': 'The occurrence of all serious adverse reactions within 6 months after vaccination (number of cases, incidence rate, and relationship with vaccination)'}, {'measure': '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', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'All SAE in the population aged ≥12 months during 0-6 months after vaccination （for phase Ⅰ）', 'timeFrame': '0-6 months after vaccination', 'description': 'All SAE in the population aged 12 months and older from the first dose to 6 months after the full course of vaccination'}, {'measure': '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', 'description': '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.'}, {'measure': 'Proportion of IgG antibodies ≥ 1.0 µg/mL and GMC results on Day 30 post-immunization（for phase Ⅱ）', 'timeFrame': '30 day after vaccination', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['26 valent pneumococcal conjugate vaccine'], 'conditions': ['Pneumococcal Vaccines']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'A single-center, randomized, double-blind, active-controlled trial design (Phase I/II) was used. In addition, according to the requirements in the approval letter of this product (2024LP01053), serum standards need to be established for the newly added types (24F, 35B). Therefore, a calibration group is set and an open study design is adopted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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;\n* 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;\n* 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;\n* Female subjects of childbearing potential agree to take effective contraceptive measures from enrollment to 6 months after vaccination.\n* For calibration group subjects: 18 to 55 years of age, ≥ 50 kg for males or ≥ 45 kg for females.\n\nExclusion Criteria:\n\n* Axillary body temperature ≥ 37.3 ℃ on the day of enrollment;\n* History of infectious diseases caused by Streptococcus pneumoniae confirmed by bacterial culture within 3 years;\n* Have received or plan to receive a Streptococcus pneumoniae vaccine outside the trial protocol, including marketed or other investigational Streptococcus pneumoniae vaccines;\n* 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;\n* Allergic to any component of the investigational vaccine;\n* 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;\n* 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.;\n* Encephalopathy, uncontrolled epilepsy, convulsion and other progressive neurological diseases, or a history or family history of mental illness;\n* Contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;\n* Asplenia or splenectomy, functional asplenia due to any condition;\n* 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);\n* 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);\n* 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.);\n* Received non-live vaccine within 7 days (≤ 7 days) or live attenuated vaccine within 14 days (≤ 14 days) prior to enrollment;\n* Hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, applicable to adults);\n* 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);\n* 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;\n* For Standardised Subjects:\n\n 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.\n* Plans to move before the end of the trial or leave the area for an extended period of time during scheduled trial visits;\n* Ongoing participation or planning to participate in other clinical trials (vaccines, drugs, medical devices, etc.) in the near future;\n* Subject has any condition that, in the opinion of the investigator, may interfere with the evaluation of the objectives of the trial.'}, 'identificationModule': {'nctId': 'NCT06703203', 'briefTitle': 'Phase I/II Clinical Trial of 26-valent Pneumococcal Conjugate Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '202417AB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '≥60 years old age group (for phase Ⅰ)', 'description': 'There are 30 subjects in ≥60 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.', 'interventionNames': ['Biological: 26-Valent pneumococcal conjugate vaccine', 'Biological: 23-Valent pneumococcal polysaccharide vaccine']}, {'type': 'OTHER', 'label': '18-59 years old age group (for phase Ⅰ)', 'description': 'There are total 40 subjects in 18-59 age group. Among them, 30 subjects were randomly assigned to the experimental group and the control group in a 2:1 ratio. In addition, other 10 subjects aged 18-55 to receive the experimental vaccine as the serum calibration test population.', 'interventionNames': ['Biological: 26-Valent pneumococcal conjugate vaccine', 'Biological: 23-Valent pneumococcal polysaccharide vaccine']}, {'type': 'OTHER', 'label': '6-17 years old age group (for phase Ⅰ)', 'description': 'There are 30 subjects in 6-17 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.', 'interventionNames': ['Biological: 26-Valent pneumococcal conjugate vaccine', 'Biological: 23-Valent pneumococcal polysaccharide vaccine']}, {'type': 'OTHER', 'label': '2-5 years old age group (for phase Ⅰ/Ⅱ)', 'description': 'There are total 230 people in 2-5 years old age group. Among them, there were 30 subjects included in the phase Ⅰ clinical trial and were randomly assigned to the experimental group and the control group in a 2:1 ratio. And the other 200 people were included for phase Ⅱ and were randomly assigned to the experimental group and the control group in a 1:1 ratio.', 'interventionNames': ['Biological: 26-Valent pneumococcal conjugate vaccine', 'Biological: 13-Valent pneumococcal conjugate vaccine']}, {'type': 'OTHER', 'label': '13-23 months old age group (for phase Ⅰ)', 'description': 'There are 30 subjects in 13-23 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.', 'interventionNames': ['Biological: 26-Valent pneumococcal conjugate vaccine', 'Biological: 13-Valent pneumococcal conjugate vaccine']}, {'type': 'OTHER', 'label': '7-11 months old age group (for phase Ⅰ)', 'description': 'There are 30 subjects in 7-11 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.', 'interventionNames': ['Biological: 26-Valent pneumococcal conjugate vaccine', 'Biological: 13-Valent pneumococcal conjugate vaccine']}, {'type': 'OTHER', 'label': '3 months old age group (for phase Ⅰ)', 'description': 'There are 30 subjects in 3 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.', 'interventionNames': ['Biological: 26-Valent pneumococcal conjugate vaccine', 'Biological: 13-Valent pneumococcal conjugate vaccine']}, {'type': 'OTHER', 'label': '2 months old age group （for phase Ⅰ）', 'description': 'There are 30 subjects in 2 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.', 'interventionNames': ['Biological: 26-Valent pneumococcal conjugate vaccine', 'Biological: 13-Valent pneumococcal conjugate vaccine']}], 'interventions': [{'name': '26-Valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': 'As an experimental group. The active ingredient of 26-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 26 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.', 'armGroupLabels': ['13-23 months old age group (for phase Ⅰ)', '18-59 years old age group (for phase Ⅰ)', '2 months old age group （for phase Ⅰ）', '2-5 years old age group (for phase Ⅰ/Ⅱ)', '3 months old age group (for phase Ⅰ)', '6-17 years old age group (for phase Ⅰ)', '7-11 months old age group (for phase Ⅰ)', '≥60 years old age group (for phase Ⅰ)']}, {'name': '23-Valent pneumococcal polysaccharide vaccine', 'type': 'BIOLOGICAL', 'description': 'As a control group. The effective ingredients of 23-valent pneumococcal polysaccharide vaccine are 23 serotypes of pneumococcal capsular polysaccharides. Administer one dose of 0.5mL each time.', 'armGroupLabels': ['18-59 years old age group (for phase Ⅰ)', '6-17 years old age group (for phase Ⅰ)', '≥60 years old age group (for phase Ⅰ)']}, {'name': '13-Valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': 'As a control group. The active ingredient of 13-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 13 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.', 'armGroupLabels': ['13-23 months old age group (for phase Ⅰ)', '2 months old age group （for phase Ⅰ）', '2-5 years old age group (for phase Ⅰ/Ⅱ)', '3 months old age group (for phase Ⅰ)', '7-11 months old age group (for phase Ⅰ)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '476700', 'city': 'Shangqiu', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Provincial Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.45, 'lon': 115.65}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}