Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-21 @ 5:48 AM
Study NCT ID:
NCT01047202
Status:
COMPLETED
Last Update Posted:
2013-03-15
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-13', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants', 'timeFrame': '3 months'}]}, 'conditionsModule': {'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '23134570', 'type': 'DERIVED', 'citation': 'Li YP, Li W, Liang XF, Liu Y, Huang XC, Li CG, Li RC, Wang JZ, Wang HQ, Yin WD. Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. Influenza Other Respir Viruses. 2013 Nov;7(6):1297-307. doi: 10.1111/irv.12028. Epub 2012 Nov 8.'}]}, 'descriptionModule': {'briefSummary': "A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male or female aged between 6 and 35 months\n2. Full-term birth, birth weight 2,500 grams or more\n3. provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent\n\nExclusion Criteria:\n\n1. Cases, cured cases and close contact of influenza A (H1N1) virus\n2. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc\n3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain\n4. Symptoms of acute infection within a week\n5. Autoimmune disease or immunodeficiency\n6. Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)\n7. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids\n8. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws\n9. History or family history of convulsions, epilepsy, brain disease and psychiatric\n10. Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen\n11. Guillain-Barre Syndrome\n12. Administration of 2009-2010 seasonal vaccine\n13. History of any blood products within 3 months\n14. Administration of any other investigational research agents within 30 days\n15. Administration of any live attenuated vaccine within 30 days\n16. Administration of subunit or inactivated vaccines within 14 days\n17. Be receiving anti-TB prophylaxis or therapy currently\n18. Axillary temperature \\> 37.0 centigrade at the time of dosing\n19. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent"}, 'identificationModule': {'nctId': 'NCT01047202', 'briefTitle': 'Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants', 'orgStudyIdInfo': {'id': 'PRO-PanFlu-4003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine', 'description': '120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart', 'interventionNames': ['Biological: Pandemic influenza A/H1N1 vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 : 15 μg pandemic influenza A/H1N1 vaccine', 'description': '120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart', 'interventionNames': ['Biological: Pandemic influenza A/H1N1 vaccine']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group 3 : 7.5 μg seasonal trivalent vaccine', 'description': '60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart', 'interventionNames': ['Biological: Seasonal trivalent vaccine']}], 'interventions': [{'name': 'Pandemic influenza A/H1N1 vaccine', 'type': 'BIOLOGICAL', 'description': 'Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose', 'armGroupLabels': ['Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine']}, {'name': 'Pandemic influenza A/H1N1 vaccine', 'type': 'BIOLOGICAL', 'description': 'Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose', 'armGroupLabels': ['Group 2 : 15 μg pandemic influenza A/H1N1 vaccine']}, {'name': 'Seasonal trivalent vaccine', 'type': 'BIOLOGICAL', 'description': 'Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose', 'armGroupLabels': ['Group 3 : 7.5 μg seasonal trivalent vaccine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guilin', 'state': 'Guangxi', 'country': 'China', 'facility': 'GuangXi Center for Diseases Control and Prevention', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}