Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-02-04 @ 8:42 PM
Study NCT ID:
NCT01511133
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2011-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2011-12-01', 'studyFirstSubmitQcDate': '2012-01-12', 'lastUpdatePostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of PCV-1 DNA and pattern of detection in the stool samples collected', 'timeFrame': 'At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)'}, {'measure': 'Presence of serum anti-PCV-1 antibody', 'timeFrame': 'At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)'}]}, 'conditionsModule': {'keywords': ['Laboratory evaluations', 'infants', 'Porcine circovirus type 1 (PCV-1)', 'serologic response', 'human rotavirus (HRV) vaccine'], 'conditions': ['Rotavirus Infection', 'Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants']}, 'referencesModule': {'references': [{'pmid': '27657348', 'type': 'DERIVED', 'citation': 'Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to test the clinical samples (stool and serum) previously collected during clinical development of HRV vaccine, to identify if there is any evidence of PCV-1 replication and/or immune response to the PCV-1 in vaccinated infants.', 'detailedDescription': 'Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infants aged 6 to 12 weeks from 4 previously conducted clinical trials, who received 2 or 3 doses of either Rotarix™ or Placebo', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects enrolled previously in randomized, double-blind and placebo-controlled studies 444563/022 (NCT00263666), 444563/033 (NCT00757770), 103477 (NCT00169455), and 104480 (NCT00137930);\n* Infants aged 6 to 12 weeks at Dose 1 vaccinated with either HRV vaccine or placebo;\n* Infants for whom sufficient residual volume of the stool samples at predetermined time points is available;\n* Infants for whom sufficient residual volume of the pre and post vaccination blood samples is available.\n\nExclusion criteria:\n\n\\- Not applicable'}, 'identificationModule': {'nctId': 'NCT01511133', 'briefTitle': 'Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in the Stool of Infants Aged 6 to 12 Weeks Following Administration of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (444563)", 'orgStudyIdInfo': {'id': '114444'}, 'secondaryIdInfos': [{'id': '444563/022', 'type': 'OTHER', 'domain': 'GSK'}, {'id': '444563/033', 'type': 'OTHER', 'domain': 'GSK'}, {'id': '103477', 'type': 'OTHER', 'domain': 'GSK'}, {'id': '104480', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HRV Group', 'description': 'Subjects received two or three doses of HRV in previous studies.', 'interventionNames': ['Procedure: Stool sample', 'Procedure: Serum sample']}, {'label': 'Placebo Group', 'description': 'Subjects received two or three doses of placebo in previous studies.', 'interventionNames': ['Procedure: Stool sample', 'Procedure: Serum sample']}], 'interventions': [{'name': 'Stool sample', 'type': 'PROCEDURE', 'description': 'Stool samples collected at pre-determined time points in previous studies will be analysed to detect the presence of PCV-1 DNA and pattern of detection.', 'armGroupLabels': ['HRV Group', 'Placebo Group']}, {'name': 'Serum sample', 'type': 'PROCEDURE', 'description': 'Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody.', 'armGroupLabels': ['HRV Group', 'Placebo Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}