Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-26 @ 1:54 AM
Study NCT ID:
NCT00192205
Status:
COMPLETED
Last Update Posted:
2006-10-03
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 2200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2003-06'}, '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 season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine'}], 'secondaryOutcomes': [{'measure': 'To demostrate that the efficacy over one season of CAIV-T is not inferior to that of TIV against culture-confirmed influenza-illness of any subtype'}, {'measure': 'To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media'}, {'measure': 'To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs'}]}, 'conditionsModule': {'conditions': ['Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': '\\- Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children.', 'detailedDescription': '* The purpose of this study is to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children with a history of recurrent RTIs aged at least 6 months and less than 72 months of age.\n* The trial also provides the opportunity to compare the efficacy of CAIV-T with TIV on acute otitis media.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '71 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* who are aged at least 6 months and less than 72 months of age at the time of enrolment;\n* who have experienced two or more practitioner attended RTIs\\* in the past 12 months (since birth if less than 12 months old); \\* RTIs are defined as upper RTIs including (but not limited to) common cold, acute otitis media and lower RTIs including (but not limited to) bronchiolitis, bronchitis and pneumonia.\n* 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* 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* 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 (i) 2mg/kg/day or greater of Prednisolone or (ii) equivalent to a total of 20 mg/day or greater for children who weigh more than 10kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued 27;\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 enrolment through to the conclusion of the study;\n* who have an immunosuppressed or an immunocompromised individual living in the same household;\n* who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational) or is 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 CAIV-T or TIV;\n* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrolment 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 enrolment or ongoing participation of the subject in the study."}, 'identificationModule': {'nctId': 'NCT00192205', 'briefTitle': 'Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children', '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 a History of Recurrent Respiratory Tract Infections Aged 6 Months to Less Than 72 Months', 'orgStudyIdInfo': {'id': 'D153-P514'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CAIV-T or TIV', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schneider Children's Medical Center of Israel", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Vitoria-Gasteiz', 'country': 'Spain', 'facility': 'Hospital de Txagorritxu', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}]}}}