Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-22 @ 5:17 PM
Study NCT ID:
NCT05313893
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects received 2 doses of an inactivated quadrivalent influenza vaccine,4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and4 weeks after dose 2.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-13', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparision between Seroconversion Rate (SCR) of HAI antibodies against each virus strain post dose 1 and dose 2', 'timeFrame': 'day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2', 'description': 'The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer \\< 1:10and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.'}, {'measure': 'Comparision between Geometric Mean Titre (GMT) of HAI antibodies against each virus strain post dose 1 and dose 2', 'timeFrame': 'day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2'}, {'measure': 'Comparision between seroprotection rates of HAI antibodies against each virus strain post dose 1 and dose 2', 'timeFrame': 'day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2', 'description': 'A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.'}, {'measure': 'Comparision between Geometric Mean Fold Increase (GMFI) of HAI antibodies against each virus strain post dose 1and dose 2', 'timeFrame': 'day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2'}], 'primaryOutcomes': [{'measure': 'the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI)antibodies against each virus strain after 2nd vaccination ≥40%', 'timeFrame': 'day 28 after dose 2', 'description': 'The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer \\< 1:10and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.'}, {'measure': 'Number of participants with Adverse Reactions (ARs)', 'timeFrame': '28 days after each vaccination', 'description': 'Frequency and severity of ARs for 28 days after each vaccination'}], 'secondaryOutcomes': [{'measure': 'the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%', 'timeFrame': 'day 28 after dose 2', 'description': 'A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.'}, {'measure': 'Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5', 'timeFrame': 'day 28 after dose 2', 'description': 'Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI)against each virus strain'}, {'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': '28 days after each vaccination', 'description': 'Frequency and severity of AEs for 28 days after each vaccination'}, {'measure': 'Number of participants with Serious Adverse Events (SAE)', 'timeFrame': '6 months after the last vaccination', 'description': 'Frequency of SAEs for 6 months after the last vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safety', 'Immunogenicity', 'Quadrivalent influenza vaccine'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination.', 'detailedDescription': 'Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 3-8 years old\n* Healthy subjects judged from medical history and clinical examination\n* Subjects themselves or their guardians able to understand and sign theinformed consent\n* Subjects themselves or their guardians can and will comply with therequirements of the protocol\n* Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment\n* Subjects with temperature \\<=37.0°C on axillary setting\n\nExclusion Criteria:\n\n* Any prior administration of other research medicine/vaccine in last 30 days\n* Any prior administration of influenza vaccine in last 6 month\n* Any prior administration of immunodepressant or corticosteroids in last 3 months\n* Any prior administration of blood products in last 3 months\n* Any prior administration of any attenuated live vaccine in last 14 days\n* Any prior administration of subunit or inactivated vaccines in last 7 days\n* Subject who developed guillain-Barre syndrome post influenza vaccination\n* Subject who is allergic to any ingredient of the vaccine\n* Subject with acute febrile illness or infectious disease\n* Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection\n* Subject with damaged or low immune function which has already beenknown\n* Subject with congenital heart disease or other birth defects unsuitable for vaccination.\n* Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections.\n* Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol"}, 'identificationModule': {'nctId': 'NCT05313893', 'briefTitle': 'A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years', 'organization': {'class': 'NETWORK', 'fullName': 'Jiangsu Province Centers for Disease Control and Prevention'}, 'officialTitle': 'A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of anInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years', 'orgStudyIdInfo': {'id': 'SJLGYM-2021-Ⅳ-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadrivalent influenza vaccine', 'description': 'Subjects received 2 doses of 0.5 mL of quadrivalentinfluenza vaccine, 4 weeks apart. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.', 'interventionNames': ['Biological: Quadrivalent influenza vaccine']}], 'interventions': [{'name': 'Quadrivalent influenza vaccine', 'type': 'BIOLOGICAL', 'description': 'Subjects receive two doses of quadrivalent influenzavaccine administered 4 weeks apart by intramuscularinjection. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.', 'armGroupLabels': ['Quadrivalent influenza vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '222300', 'city': 'Lianyungang', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Donghai County Center for Disease Control and Prevention', 'geoPoint': {'lat': 34.59845, 'lon': 119.21556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Province Centers for Disease Control and Prevention', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}