Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 2:20 AM
Study NCT ID:
NCT06314867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 990}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric mean concentration (GMC) levels', 'timeFrame': '30 days after immunization', 'description': 'Geometric mean concentration (GMC) levels of 23 serotype specific IgG antibodies'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['23 Valent Pneumococcal Polysaccharide Vaccine'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine.', 'detailedDescription': 'This study adopted a randomized, double-blind, equivalency design with different batches of experimental vaccine. 990 individuals aged 18-59 were included and divided into three groups at a ratio of 1:1:1, with 330 individuals in each group receiving three batches of experimental vaccines, respectively. All subjects were vaccinated with 1 dose of 0.5ml, intramuscularly injected into the lateral deltoid muscle of the upper arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers aged 18-59;\n* Voluntarily participate and sign an informed consent form;\n* Subjects are able to comply with the requirements of the clinical study protocol and complete the prescribed follow-up;\n* Has not received pneumococcal vaccine or any other preventive products recently (has not received attenuated live vaccine within 14 days, has not received inactivated vaccine within 7 days);\n* Underarm temperature ≤ 37.0 ℃;\n* Female participants of childbearing age agree to take effective contraceptive measures within 3 months from the start of the study until the full vaccination period.\n\nExclusion Criteria:\n\n* Subjects with a history or family history of progressive neurological disorders such as epilepsy, encephalopathy, and mental illness;\n* Has a history of severe allergies to any drugs or vaccines in the past;\n* Has a allergy history to any component of the experimental vaccine (the main components of the vaccine include type 23 pneumococcal polysaccharides, sodium chloride, sodium dihydrogen phosphate, and sodium dihydrogen phosphate);\n* Suffering from severe cardiovascular diseases (heart disease, pulmonary heart disease, pulmonary edema, drug-resistant hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg)); drug-resistant diabetes;\n* Subjects with a history of thrombocytopenia or other coagulation disorders that may cause contraindications for subcutaneous injection;\n* Subjects with known immunological dysfunction or low levels, or HIV infection;\n* Any situation leading to splenomegaly, splenectomy, or functional splenomegaly;\n* Malignant tumors, active or treated tumors that have not been clearly cured, or are likely to recur during the study period;\n* Anti tuberculosis prevention or treatment is under way;\n* Subjects who are participating in or planning to participate in clinical trials of other drugs or vaccine clinical trials throughout the entire observation period;\n* Women of childbearing age are in pregnancy (positive urine pregnancy test) or lactation period;\n* Any situation that the researcher believes may affect the evaluation of the study.'}, 'identificationModule': {'nctId': 'NCT06314867', 'briefTitle': 'Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd'}, 'officialTitle': 'A Single Center, Randomized, Double-blind, and Intergroup Control Clinical Study to Evaluation on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of 23 Valent Pneumococcal Polysaccharide Vaccine', 'orgStudyIdInfo': {'id': '20220231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)', 'description': 'Batch number: Y202112011', 'interventionNames': ['Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)']}, {'type': 'EXPERIMENTAL', 'label': '23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)', 'description': 'Batch number: Y202112012', 'interventionNames': ['Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)']}, {'type': 'EXPERIMENTAL', 'label': '23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)', 'description': 'Batch number: Y202112013', 'interventionNames': ['Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)']}], 'interventions': [{'name': '23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)', 'type': 'BIOLOGICAL', 'description': 'All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112011), intramuscularly injected into the lateral deltoid muscle of the upper arm.', 'armGroupLabels': ['23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)']}, {'name': '23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)', 'type': 'BIOLOGICAL', 'description': 'All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112012), intramuscularly injected into the lateral deltoid muscle of the upper arm.', 'armGroupLabels': ['23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)']}, {'name': '23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)', 'type': 'BIOLOGICAL', 'description': 'All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112013), intramuscularly injected into the lateral deltoid muscle of the upper arm.', 'armGroupLabels': ['23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Sichuan Center for Disease Control and Prevention', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Lin Du', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}