Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT04841369
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2021-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}], 'ancestors': [{'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}]}}, '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': 3420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2021-04-08', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of PCV13i in preventing pneumococcal infections', 'timeFrame': 'Within 7 days post each vaccination', 'description': 'Occurance of adverse reactions in all subjects'}, {'measure': 'Safety of PCV13i in preventing pneumococcal infections', 'timeFrame': 'Within 30 days post each vaccination', 'description': 'Occurance of adverse reactions in all subjects'}, {'measure': 'Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)', 'timeFrame': '30 days post three doses', 'description': 'Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml'}, {'measure': 'Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)', 'timeFrame': '30 days post three doses', 'description': 'Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml'}, {'measure': 'Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)', 'timeFrame': '30 days post last dose of vaccination', 'description': 'Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml'}, {'measure': 'Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)', 'timeFrame': '30 days post vaccination', 'description': 'Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml'}], 'secondaryOutcomes': [{'measure': 'Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)', 'timeFrame': '30 days post three doses', 'description': 'GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio'}, {'measure': 'Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)', 'timeFrame': '30 days post three doses', 'description': 'Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml'}, {'measure': 'Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)', 'timeFrame': '6 months post one to three doses of vaccination', 'description': 'Occurance of SAE in subjects of this age group'}, {'measure': 'Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)', 'timeFrame': '30 days post two doses', 'description': 'GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio'}, {'measure': 'Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)', 'timeFrame': '30 days post last dose of vaccination', 'description': 'GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio'}, {'measure': 'Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B)', 'timeFrame': '30 days post two doses', 'description': 'Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml'}, {'measure': 'Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)', 'timeFrame': '30 days post last dose of vaccination', 'description': 'Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml'}, {'measure': 'Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B)', 'timeFrame': '6 months post two doses', 'description': 'Occurance of SAE in subjects of this age group'}, {'measure': 'Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)', 'timeFrame': '6 months post last dose of vaccination', 'description': 'Occurance of SAE in subjects of this age group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCV13', '13 valent Pneumococcal conjugate vaccine', 'Pneumococcal Infections', 'Safety', 'Immunogenicity'], 'conditions': ['Pneumococcal Infections', 'Streptococcal Infections', 'Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;\n* Willing to provide proof of identity;\n* Without vaccination history of pneumococcal vaccine;\n* None-pregnancy or do not plan to pregnancy recently;;\n* Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;\n* Volunteers of 8-17 years old and their guardians who willing sign informed consent;\n* Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;\n* Able and willing comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Volunteers whose axillary body temperature was \\>37.0# before vaccination\n* Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;\n* Volunteers who has a history of epilepsy, convulsions or psychosis;\n* Allergic person;\n* Any prior administration of blood products in last 3 month;\n* Any prior administration of other research medicines in last 1 month;\n* Plans to participate in or is participating in any other drug clinical study;\n* Any prior administration of attenuated live vaccine in last 14 days;\n* Any prior administration of subunit or inactivated vaccines in last 7 days;\n* Had fever before vaccination, Volunteers with temperature \\>37.0°C on axillary setting;\n* According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial"}, 'identificationModule': {'nctId': 'NCT04841369', 'briefTitle': 'Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CanSino Biologics Inc.'}, 'officialTitle': 'A Randomized,Blind, Positive-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） in Healthy People Aged 6 Weeks and Above', 'orgStudyIdInfo': {'id': 'CS-CTP-PCV-III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1A', 'description': 'Subjects received four doses of PCV13i at 2 months of age (At least 6 weeks old)', 'interventionNames': ['Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1B', 'description': 'Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old)', 'interventionNames': ['Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '2A', 'description': 'Subjects received four doses of PCV13i at 3 months of age', 'interventionNames': ['Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）']}, {'type': 'EXPERIMENTAL', 'label': '3A', 'description': 'Subject received three doses of PCV13i at 7 to 11 months of age', 'interventionNames': ['Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3B', 'description': 'Subject received three doses of PCV13 at 7 to 11 months of age', 'interventionNames': ['Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': '4A', 'description': 'Subjects received two doses of PCV13i at 12 to 23 months of age', 'interventionNames': ['Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4B', 'description': 'Subjects received two doses of PCV13 at 12 to 23 months of age', 'interventionNames': ['Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5A', 'description': 'Subjects received one dose of PCV13i at 2 to 5 years old.', 'interventionNames': ['Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5B', 'description': 'Subjects received one dose of PCV13 at 2 to 5 years old.', 'interventionNames': ['Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine']}], 'interventions': [{'name': '13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）', 'type': 'BIOLOGICAL', 'otherNames': ['PCV13i'], 'description': '0.5mL,Intramuscular', 'armGroupLabels': ['1A', '2A', '3A', '4A', '5A']}, {'name': '13-Valent Pneumococcal Polysaccharide Conjugate Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Prevnar'], 'description': '0.5mL,Intramuscular', 'armGroupLabels': ['1B', '3B', '4B', '5B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450016', 'city': 'Anyang', 'state': 'Henan', 'country': 'China', 'facility': 'Neihuang Center for Disease Control and Prevention', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}], 'overallOfficials': [{'name': 'Shengli Xia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henan Province Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CanSino Biologics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Henan Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}