Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02451969
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2015-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1760}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2015-05-20', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes', 'timeFrame': '28 days', 'description': 'For each serotype, the SCR is the percentage of participants with the increase of relative antibody concentration ≥ 2 folds after vaccination. The relative antibody concentrations were measured using Enzyme Linked Immunosorbent Assay (ELISA).'}], 'secondaryOutcomes': [{'measure': 'The incidences of adverse events (AEs)', 'timeFrame': '28 days', 'description': 'After each injection, a 30-minute safety observation was conducted immediately. The body temperature, occurrence of solicited local and general AEs on day 0 - 7 were reported. Unsolicited AEs occurred during day 0 - 28 were also reported. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination).'}, {'measure': 'The increases of relative antibody concentration against each of the 23 pneumococcal serotypes', 'timeFrame': '28 days', 'description': 'The relative antibody concentrations in the pre- and post-immunization serum samples were measured using ELISA.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infections']}, 'referencesModule': {'references': [{'pmid': '30215583', 'type': 'DERIVED', 'citation': 'Huang L, Wang L, Li H, Hu Y, Ru W, Han W, Shi G, Ye Q, Han Z, Xia J, Xia S, Xu M, Li J. A phase III clinical trial to evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy children, adults, and elderly. Hum Vaccin Immunother. 2019;15(1):249-255. doi: 10.1080/21645515.2018.1509648. Epub 2018 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV.', 'detailedDescription': 'This study is a randomized, double-blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. The primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological products Co., Ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer ≥ 2 years old;\n* Proven legal identity;\n* Written consent of the guardian of participants \\< 18 years old, and written consent of the participant ≥ 12 years old;\n* Complying with the requirement of the study protocol;\n\nExclusion Criteria:\n\n* Prior vaccination with pneumococcal vaccine;\n* History of bacterial pneumonia within 3 years prior to this study;\n* Pregnant, breast feeding, or women expected to conceive within 60 days after vaccination;\n* History of allergy to any vaccine or vaccine ingredient;\n* Receipt of any of the following products:\n\n 1. Blood product within 3 months prior to study entry;\n 2. Any live attenuated vaccine within 28 days prior to study entry;\n 3. Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;\n 4. Any immunosuppressant within 6 month prior to study entry;\n* Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor;\n* History of asthma, thyroidectomy, angioneurotic edema, severe nervous system disease or mental illness; without spleen or splenectomy; diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;\n* Acute disease or acute stage of chronic disease within 7 days prior to study entry;\n* Axillaty temperature \\> 37.0 °C;\n* Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;\n* Participants with the following conditions from day 0 - 28 would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS):\n\n 1. Receipt of any other investigational or unregistered product (drug or vaccine);\n 2. Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for \\> 14 days, except for inhalant or locally administrated corticosteroid;\n 3. Receipt of immunoglobulin and/or blood product;\n 4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);'}, 'identificationModule': {'nctId': 'NCT02451969', 'briefTitle': 'Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'Phase III Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine: A Double-blind, Randomized and Controlled Clinical Trial With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly', 'orgStudyIdInfo': {'id': 'PRO-PPV-3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': '* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0\n* Intervention: investigational 23-valent PPV', 'interventionNames': ['Biological: investigational 23-valent PPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': '* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0\n* Intervention: control 23-valent PPV', 'interventionNames': ['Biological: control 23-valent PPV']}], 'interventions': [{'name': 'investigational 23-valent PPV', 'type': 'BIOLOGICAL', 'description': 'The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.', 'armGroupLabels': ['Experimental Group']}, {'name': 'control 23-valent PPV', 'type': 'BIOLOGICAL', 'description': 'The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '475100', 'city': 'Kaifeng', 'state': 'Henan', 'country': 'China', 'facility': 'Kaifeng County Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.7986, 'lon': 114.30742}}], 'overallOfficials': [{'name': 'Weiping Ru, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Provincial Center for Disease Control and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}