Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT01192958
Status:
COMPLETED
Last Update Posted:
2010-09-01
First Post:
2010-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}], 'ancestors': [{'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-31', 'studyFirstSubmitDate': '2010-08-31', 'studyFirstSubmitQcDate': '2010-08-31', 'lastUpdatePostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['swine flu', 'novel h1n1v', 'novel h1n1', 'h1n1'], 'conditions': ['H1N1 Virus']}, 'descriptionModule': {'briefSummary': 'At present influenza immunity can only be reliably confirmed by a blood test. This test is invasive for the patient. This study is intended to validate an oral fluid/saliva antibody test for the variant Swine Influenza H1N1. If such a test were available, this painless and non invasive test will improve direct clinical care to an individual as well as significantly help guide future public health management of the pandemic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects from primary care who are participating in the clinical service evaluation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants of the clinical service evaluation of novel H1N1v vaccine\n* First or second blood sample for the clinical service evaluation successfully collected\n\nExclusion Criteria:\n\n* Withdrawn from clinical service evaluation of novel H1N1v vaccine\n* Second blood sample for the clinical service evaluation not collected.'}, 'identificationModule': {'nctId': 'NCT01192958', 'acronym': 'Snuffles', 'briefTitle': 'A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Public Health England'}, 'officialTitle': 'A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza', 'orgStudyIdInfo': {'id': 'OFLU'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Public Health England', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Professor Liz Miller', 'oldOrganization': 'Health Protection Agency'}}}}