Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-03 @ 6:46 AM
Study NCT ID:
NCT00808392
Status:
COMPLETED
Last Update Posted:
2011-12-29
First Post:
2008-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 916}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-26', 'studyFirstSubmitDate': '2008-12-12', 'studyFirstSubmitQcDate': '2008-12-12', 'lastUpdatePostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.', 'timeFrame': '90 days'}]}, 'conditionsModule': {'keywords': ['vaccine', 'prevention', 'haemophilus influenzae type b', 'children'], 'conditions': ['Haemophilus Influenzae Type b']}, 'descriptionModule': {'briefSummary': 'This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants of either sex, aged 2 - 4 months\n* In good health as determined by:\n\n * medical history\n * physical examination\n * clinical judgment of the investigator;\n* Available for all visits scheduled in the study and able to comply with all study regulations\n* For whom written informed consent has been obtained from at least one parent or legal guardian\n\nExclusion Criteria:\n\n* Parent or legal guardian is unwilling or unable to give written informed consent to participate in study\n* Infants who have received any other Haemophilus influenzae type b immunization dose before\n* Infants who presented a previous disease potentially related to Haemophilus influenzae type b\n* Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease\n* Premature (before 37th week of gestation) or birth weight less than 2500 g\n* History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component\n* Fever ≥ 38.0 °C (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment\n* Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease\n* Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder\n* Subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder\n* Subjects with a clinically significant genetic anomaly\n* Treatment with corticosteroids or other immunosuppressive drugs\n* Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives\n* Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.\n* Participation in any other investigational trial simultaneously\n* Planned surgery during the study period\n* Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective'}, 'identificationModule': {'nctId': 'NCT00808392', 'briefTitle': 'Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart', 'orgStudyIdInfo': {'id': 'M37P2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: Haemophilus influenzae type b vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Biological: Commercial Haemophilus influenzae type b vaccine']}], 'interventions': [{'name': 'Haemophilus influenzae type b vaccine', 'type': 'BIOLOGICAL', 'description': '3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine', 'armGroupLabels': ['1']}, {'name': 'Commercial Haemophilus influenzae type b vaccine', 'type': 'BIOLOGICAL', 'description': '3 doses one month apart of Haemophilus influenzae type b vaccine.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '072650', 'city': 'Dingxing', 'state': 'Hebei', 'country': 'China', 'facility': 'the CDC of Dingxing county(site no 02)', 'geoPoint': {'lat': 39.26423, 'lon': 115.79055}}, {'zip': '050800', 'city': 'Zhengding', 'state': 'Hebei', 'country': 'China', 'facility': 'The CDC of Zhengding county(site no 01)', 'geoPoint': {'lat': 38.14501, 'lon': 114.56556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}