Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT04790851
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2021-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D011018', 'term': 'Pneumonia, Pneumococcal'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'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': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'serum testing technicians were masked.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion rate (COVAX)', 'timeFrame': 'Results obtained 28 days after the first dose (= right before the second dose)', 'description': 'the rate of positive seroconversion against coronavirus'}, {'measure': 'Seroconversion rate (COVAX)', 'timeFrame': 'Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)', 'description': 'the rate of positive seroconversion against coronavirus'}, {'measure': 'Neutralizing antibody level (COVAX)', 'timeFrame': 'Baseline (before vaccination) results', 'description': 'neutralizing antibody level against coronavirus'}, {'measure': 'Neutralizing antibody level (COVAX)', 'timeFrame': 'Results obtained 28 days after the first dose (= right before the second dose)', 'description': 'neutralizing antibody level against coronavirus'}, {'measure': 'Neutralizing antibody level (COVAX)', 'timeFrame': 'Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)', 'description': 'neutralizing antibody level against coronavirus'}, {'measure': 'Seropositive rate (IIV4)', 'timeFrame': 'Baseline (before vaccination) results', 'description': 'the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses'}, {'measure': 'Seroconversion rate (IIV4)', 'timeFrame': 'Results obtained 28 days after the first dose (= right before the second dose)', 'description': 'the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses'}, {'measure': 'Seroconversion rate (IIV4)', 'timeFrame': 'Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)', 'description': 'the rate of positive seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses'}, {'measure': 'Hemmagglution inhibition antibody level (IIV4)', 'timeFrame': 'Baseline (before vaccination) results', 'description': 'Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses'}, {'measure': 'Hemmagglution inhibition antibody level (IIV4)', 'timeFrame': 'Results obtained 28 days after the first dose (= right before the second dose)', 'description': 'Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses'}, {'measure': 'Hemmagglution inhibition antibody level (IIV4)', 'timeFrame': 'Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)', 'description': 'Hemmagglution inhibition antibody levels against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses'}, {'measure': 'Seroconversion rate (PPV23)', 'timeFrame': 'Results obtained 28 days after the first dose (= right before the second dose)', 'description': 'the rate of positive seroconversion against 23 pneumococcal serotypes'}, {'measure': 'Seroconversion rate (PPV23)', 'timeFrame': 'Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)', 'description': 'the rate of positive seroconversion against 23 pneumococcal serotypes'}, {'measure': 'Neutralizing antibody level (PPV23)', 'timeFrame': 'Baseline (before vaccination) results', 'description': 'Neutralizing antibody level against 23 pneumococcal serotypes'}, {'measure': 'Neutralizing antibody level (PPV23)', 'timeFrame': 'Results obtained 28 days after the first dose (= right before the second dose)', 'description': 'Neutralizing antibody level against 23 pneumococcal serotypes'}, {'measure': 'Neutralizing antibody level (PPV23)', 'timeFrame': 'Results obtained after the second dose of vaccination (= 56 days after the first dose, or 28 days after the second dose)', 'description': 'Neutralizing antibody level against 23 pneumococcal serotypes'}], 'secondaryOutcomes': [{'measure': 'Adverse events following vaccination', 'timeFrame': '0-6 months', 'description': 'analyse the incidence of adverse events following immunization, both solicited and unsolicited'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza, Human', 'Pneumonia, Pneumococcal', 'Covid19']}, 'referencesModule': {'references': [{'pmid': '35931636', 'type': 'DERIVED', 'citation': 'Chen H, Huang Z, Chang S, Hu M, Lu Q, Zhang Y, Wang H, Xiao Y, Wang H, Ge Y, Zou Y, Cui F, Han S, Zhang M, Wang S, Zhu X, Zhang B, Li Z, Ren J, Chen X, Ma R, Zhang L, Guo X, Luo L, Sun X, Yang X. Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial. Vaccine. 2022 Aug 26;40(36):5322-5332. doi: 10.1016/j.vaccine.2022.07.033. Epub 2022 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'Subjects will be recruited and divided into 3 groups:\n\nExperimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects): 1st dose: IIV4 only, 2nd dose: PPV23 only.\n\nBlood samples will be collected 3 times:\n\nbefore the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination.\n\nThe immunogenicity and safety of both experimental and control groups will be analyzed.', 'detailedDescription': 'This randomized, parallel, controlled study is designed to evaluate the immunogenicity and safety of simultaneously immunization of COVAX + PPV23 and COVAX + IIV4.\n\n1152 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 384 subjects respectively.\n\nExperimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects) will receive: 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects) will receive: 1st dose: IIV4 only, 2nd dose: PPV23 only.\n\nSpecifically, each group will be divided again. Each 384-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old.\n\nEach subgroup includes 192 subjects respectively. Blood samples will be collected 3 times: (1) before the 1st dose of vaccinatioin; (2) before the 2nd dose of vaccination; (3) 28 days after the 2nd dose of vaccination.\n\nTo evaluate the immunogenicity, the investigators will detect and compare the neutralizing antibody levels, the seroconversion rates and antibody geometric mean concentrations.\n\nThe safety of all groups will be monitored as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* ≥18 years old when enrolled;\n* Participants signing the informed consent;\n* Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview;\n* Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment;\n* ≥14 days from the most recent vaccination;\n* Before enrollment, the body temperature is ≤37.0C as confirmed by medical history and clinical examination.\n\nExclusion criteria for the first dose:\n\n* Having a history of COVID-19 or a positive nucleic acid test for COVID-19;\n* Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness;\n* Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine;\n* Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder;\n* Having injection of non-specific immunoglobulin within 1 month prior to enrollment;\n* Having acute febrile illness or communicable disease;\n* Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection;\n* Having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes;\n* Having various infectious, pyogenic, or allergic skin diseases;\n* Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination;\n* Having any condition that may affect trial assessment as determined by researchers.\n\nExclusion criteria for the second dose:\n\n* Having any serious adverse event related to the first dose vaccination;\n* After vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers;\n* Having a newly emerging condition that meets the exclusion criteria for the first dose;\n* Having any condition that may affect trial assessment as determined by researchers.'}, 'identificationModule': {'nctId': 'NCT04790851', 'briefTitle': 'Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4', 'organization': {'class': 'INDUSTRY', 'fullName': 'China National Biotec Group Company Limited'}, 'officialTitle': 'A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVAX) (Produced in Beijing) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)', 'orgStudyIdInfo': {'id': 'COVAX+PPV23+IIV4-Beijing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23', 'interventionNames': ['Biological: COVAX+IIV4; COVAX+PPV23']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group A', 'description': 'Control Group A (384 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only', 'interventionNames': ['Biological: COVAX only (1st and 2nd dose)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group B', 'description': 'Control Group B (384 subjects) will receive: 1st dose: IIV4 only; 2nd dose: PPV23 only', 'interventionNames': ['Biological: IIV4 for the 1st dose and PPV23 for the 2nd dose']}], 'interventions': [{'name': 'COVAX+IIV4; COVAX+PPV23', 'type': 'BIOLOGICAL', 'description': '1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23', 'armGroupLabels': ['Experimental group']}, {'name': 'COVAX only (1st and 2nd dose)', 'type': 'BIOLOGICAL', 'description': '1st dose: COVAX only; 2nd dose: COVAX only', 'armGroupLabels': ['Control group A']}, {'name': 'IIV4 for the 1st dose and PPV23 for the 2nd dose', 'type': 'BIOLOGICAL', 'description': '1st dose: IIV4 only; 2nd dose: PPV23 only', 'armGroupLabels': ['Control group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'Sichuan Center for Disease Control and Prevention', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '200336', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Municipal Center for Disease Control and Prevention', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030012', 'city': 'Taiyuan', 'country': 'China', 'facility': 'Shanxi Provincial Center for Disease Control and Prevention', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'overallOfficials': [{'name': 'Xiaodong Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Municipal Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Biotec Group Company Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chengdu Institute of Biological Products Co.,Ltd.', 'class': 'INDUSTRY'}, {'name': 'Changchun Institute of Biological Products Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Beijing Institute of Biological Products Co Ltd.', 'class': 'INDUSTRY'}, {'name': 'Sichuan Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, {'name': 'Shanghai Municipal Center for Disease Control and Prevention', 'class': 'OTHER'}, {'name': 'Centers for Disease Control and Prevention, China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}