Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-04 @ 4:51 PM
Study NCT ID:
NCT00192257
Status:
COMPLETED
Last Update Posted:
2006-10-03
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 2229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2003-05'}, 'lastUpdateSubmitDate': '2006-10-02', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2006-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demostrate that the efficacy over one influenza season against culture-confirmed influenza illness caused by community-acquired subtypes antifenically similar to those contained in the vaccine'}], 'secondaryOutcomes': [{'measure': 'To demonstrate that the efficacy over one season of a single dose of CAIV-T was not inferior to that of one dose of TIV against culture-confirmed influenza-illness of any subtype'}, {'measure': 'To compare the efficacy over a defined surveillance period against asthma exacerbations, asthma medication, clinical visits, hospitalizations, days off school (pharma-ecomonic measures) associated with influenza-like illness'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': '\\- Trial to assess asthma exacerbation through to the end of the study; and to demonstrate that the efficacy over one season against culture-confirmed influenza-illness; and finally to assess the safety and tolerability of CAIV-T in children with asthma.', 'detailedDescription': '\\- To assess asthma exacerbation, being defined as acute wheezing illness associated with hospitalization, unscheduled clinic visits, or new prescriptions from study vaccination through to the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* who are aged at least 6 years to 17 years of age at the time of enrollment;\n* with a clinical diagnosis of asthma by one of the following criteria:\n* An International Classification of Diseases, Ninth revision (ICD-9) code 493 AND ≥one prescription for asthma medication;\n* OR ≥one prescription for an inhaled beta-agonist and ≥one prescription for cromolyn;\n* OR ≥Five prescriptions for any asthma medication (adapted from Kramarz et al,2000 and Osborne et al., 1995)1,2;\n* asthma medication\\* is being defined as:\n* inhaled and oral β -agonists\n* theophyllin\n* inhaled, oral and injected steroids\n* other unclassified asthma medication\n* antibiotics used for treatment of respiratory illness associated with a wheezing episode;\n* at least one asthma medication should have been administered in the last 12 months\n* who, if female and is post-menarche, has provided a negative pregnancy test prior to the study vaccination;\n* who have provided written informed consent (as appropriate and according to national guidelines) and whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained;\n* who, along with their parent(s)/legal guardian(s), will be available for duration of the trial;\n* who/whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts \\[telephone, clinic or home visit\\].\n\nExclusion Criteria:\n\n* who/whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;\n* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;\n* with Down's syndrome or other known cytogenetic disorders;\n* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids of a dose equivalent to a total of 20 mg/day or greater of prednisolone or equivalent, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 25;\n* who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;\n* for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;\n* who have an immunosuppressed or an immunocompromised individual living in the same household;\n* who received any influenza vaccine in the 6 months prior to enrollment, or are anticipated to receive a non-study influenza vaccine after enrollment;\n* with a documented history of hypersensitivity to egg or egg protein or any other component of the CAIV-T or TIV;\n* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study;\n* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results;\n\nNote: Pregnancy in any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study."}, 'identificationModule': {'nctId': 'NCT00192257', 'briefTitle': 'Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus in Children With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, Trivalent, Type A&B, Live, Cold-Adapted (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children With Asthma Aged 6 Years to 17 Years', 'orgStudyIdInfo': {'id': 'D153-P515'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CAIV-T and TIV', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berchem', 'country': 'Belgium', 'geoPoint': {'lat': 51.19021, 'lon': 4.43264}}, {'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Robert Walker, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}]}}}