Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-04 @ 2:03 PM
Study NCT ID:
NCT05499351
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2022-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Booster Immunization With COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity index of seroconversion rate of the neutralizing antibody', 'timeFrame': '28 days after the booster immunization with the third dose of COVID-19 vaccine', 'description': 'Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 28 days after the booster immunization with the third single dose of COVID-19 vaccine'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity index of seropositivity rate of the neutralizing antibody', 'timeFrame': '28 days after combined immunization', 'description': 'Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization'}, {'measure': 'Immunogenicity index of GMT of the neutralizing antibody', 'timeFrame': '28 days after combined immunization', 'description': 'GMT of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization'}, {'measure': 'Immunogenicity index of GMI of the neutralizing antibody', 'timeFrame': '28 days after combined immunization', 'description': 'GMI of the neutralizing antibody to live SARS-CoV-2 28 days after combined immunization.'}, {'measure': 'Immunogenicity index of seroconversion rate of 23 pneumonia antibodies', 'timeFrame': '28 days after single and combined vaccination of 23 valent pneumonia vaccine', 'description': 'Seroconversion rate of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine.'}, {'measure': 'Immunogenicity index of GMC increase of 23 pneumonia antibodies', 'timeFrame': '28 days after single and combined vaccination of 23 valent pneumonia vaccine', 'description': 'GMC increase of 23 pneumonia antibodies 28 days after single and combined vaccination of 23 valent pneumonia vaccine'}, {'measure': 'Immunogenicity index of seroconversion rate of 4 influenza antibodies', 'timeFrame': '28 days after single and combined vaccination', 'description': 'Seroconversion rate of 4 influenza antibodies 28 days after single and combined vaccination'}, {'measure': 'Immunogenicity index of GMT of 4 influenza antibodies', 'timeFrame': '28 days after single and combined vaccination', 'description': 'GMT of 4 influenza antibodies 28 days after single and combined vaccination'}, {'measure': 'Immunogenicity index of GMI of 4 influenza antibodies', 'timeFrame': '28 days after single and combined vaccination', 'description': 'GMI of 4 influenza antibodies 28 days after single and combined vaccination'}, {'measure': 'Immunogenicity index of protection rate of 4 influenza antibodies', 'timeFrame': '28 days after single and combined vaccination', 'description': 'Protection rate of 4 influenza antibodies 28 days after single and combined vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is a single center , randomized ,controlled and open-label phase â…£clinical trial of the booster immunization with the third dose of inactivated COVID-19 vaccine(CoronaVac)manufactured by Sinovac Research \\& Development Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the third dose of COVID-19 vaccine,inactivated (Vero Cell) co-administration with influenza vaccine and pneumococcal polysaccharide vaccine in healthy population aged 18 years and older.', 'detailedDescription': 'This study is a single center , randomized ,controlled and open-label phase â…£clinical trial in healthy adult aged 18 years and older. The purpose of this study is to evaluate the immunogenicity and safety of the third dose of COVID-19 vaccine,inactivated (Vero Cell) co-administration with influenza vaccine and pneumococcal polysaccharide vaccine.The COVID-19 vaccine was manufactured by Sinovac Research \\&Development Co., Ltd,and the quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.A total of 3000 subjects will be enrolled, with 300 aged 18\\~59years(adult group) and 300 aged 60 years and above(adult group) in the section of immunogenicity and safety of combined immunization ,with 1200 aged 18\\~59 years(adult group) and 1200 aged 60 years and above(elderly Group) in the section of safety observation study of combined immunization.Each age group will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine in the section of immunogenicity and safety of combined immunization and each age group will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine in the section of safety observation study of combined immunization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults aged 18 years and above;\n* Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \\& Development Co., Ltd at an interval of 6 months or more;\n* Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;\n* Proven legal identity;\n\nExclusion Criteria:\n\n* History of SARS-CoV-2 infection;\n* Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \\& Development Co., Ltd at an interval of less than 6 months;\n* Have received received any circulating seasonal influenza vaccine;\n* Have received any pneumococcal vaccine within 5 years;\n* History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;\n* History of uncontrolled epilepsy and other serious neurological diseases such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases;\n* History of fever at the time of vaccination, or acute onset of chronic disease, or severe uncontrolled chronic disease, or acute disease;\n* Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;\n* Receipt of other investigational drugs in the past 30 days;\n* Receipt of attenuated live vaccines in the past 14 days;\n* Receipt of inactivated or subunit vaccines in the past 7 days;\n* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial."}, 'identificationModule': {'nctId': 'NCT05499351', 'briefTitle': 'A Study of Booster Immunization With COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'A Single Center, Randomized ,Controlled and Open Clinical Trial to Evaluate the Immunogenicity and Safety of the Booster Immunization With the Third Dose of COVID-19 Vaccine,Inactivated Co -Administration With Influenza Vaccine and Pneumococcal Polysaccharide Vaccine', 'orgStudyIdInfo': {'id': 'PRO-nCOV-MA4005-BJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adult group in immunogenicity and safety study of combined immunization', 'description': '300 participants will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine', 'interventionNames': ['Biological: Adult group in immunogenicity and safety study of combined immunization']}, {'type': 'EXPERIMENTAL', 'label': 'Elderly group in immunogenicity and safety study of combined immunization', 'description': '300 participants will be randomly divided into 3 subgroups of 100 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine', 'interventionNames': ['Biological: Elderly group in immunogenicity and safety study of combined immunization']}, {'type': 'EXPERIMENTAL', 'label': 'Adult group in safety observation study of combined immunization', 'description': '1200 participants will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine', 'interventionNames': ['Biological: Adult group in safety observation study of combined immunization']}, {'type': 'EXPERIMENTAL', 'label': 'Elderly group in safety observation study of combined immunization', 'description': '1200 participants will be randomly divided into 2 subgroups of 600 people per group, each subject will receive 1 dose of COVID-19 vaccine, 1 dose of influenza vaccine and 1 dose of pneumonia vaccine', 'interventionNames': ['Biological: Elderly group in safety observation study of combined immunization']}], 'interventions': [{'name': 'Adult group in immunogenicity and safety study of combined immunization', 'type': 'BIOLOGICAL', 'description': 'The COVID-19 vaccine was manufactured by Sinovac Research \\& Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.', 'armGroupLabels': ['Adult group in immunogenicity and safety study of combined immunization']}, {'name': 'Elderly group in immunogenicity and safety study of combined immunization', 'type': 'BIOLOGICAL', 'description': 'The COVID-19 vaccine was manufactured by Sinovac Research \\& Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.', 'armGroupLabels': ['Elderly group in immunogenicity and safety study of combined immunization']}, {'name': 'Adult group in safety observation study of combined immunization', 'type': 'BIOLOGICAL', 'description': 'The COVID-19 vaccine was manufactured by Sinovac Research \\& Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.', 'armGroupLabels': ['Adult group in safety observation study of combined immunization']}, {'name': 'Elderly group in safety observation study of combined immunization', 'type': 'BIOLOGICAL', 'description': 'The COVID-19 vaccine was manufactured by Sinovac Research \\& Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co.The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.', 'armGroupLabels': ['Elderly group in safety observation study of combined immunization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100013', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Centers for Diseases Control and Prevention', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jiang Wu, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}