Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-11 @ 4:01 PM
Study NCT ID:
NCT02153333
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2014-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serologic Response to Porcine Circovirus Type 1 (PCV-1) in 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 samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2014-05-15', 'studyFirstSubmitQcDate': '2014-05-29', 'lastUpdatePostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seropositivity rates for anti-PCV-1 antibodies.', 'timeFrame': 'At 1-2 months post dose 2 of HRV vaccine or placebo.'}, {'measure': 'Seroconversion rates for anti-PCV-1 antibodies.', 'timeFrame': 'At 1-2 months post dose 2 of HRV vaccine or placebo.'}]}, 'conditionsModule': {'keywords': ['Human rotavirus (HRV) vaccine', 'Serologic response', 'Porcine circovirus type 1 (PCV-1)', 'Laboratory evaluations'], 'conditions': ['Infections, Rotavirus']}, '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 evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.', 'detailedDescription': 'Serum samples collected from 6 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 6 previously completed clinical trials, who received 2 doses of either Rotarix™ or Placebo.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNot applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:\n\n* Subjects who received two doses of HRV vaccine or Placebo and were included in the ATP cohort for immunogenicity in the primary studies listed.\n* Subjects for whom their parents or Legally Acceptable Representatives (LARs) had agreed that their child or wards blood samples could be used for further research while giving consent for any of the primary studies listed.\n* Subjects who have sufficient residual volume of serum samples at both pre- and post-vaccination time points.\n\nExclusion Criteria:\n\n* Not Applicable'}, 'identificationModule': {'nctId': 'NCT02153333', 'briefTitle': 'Serologic Response to Porcine Circovirus Type 1 (PCV-1) in 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) in Infants Following the Administration of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus Vaccine (444563)", 'orgStudyIdInfo': {'id': '114793'}, 'secondaryIdInfos': [{'id': '444563/005 (Rota-005)'}, {'id': '444563/023 (Rota-023)'}, {'id': '444563/028 (Rota-028)'}, {'id': '444563/029 (Rota-029)'}, {'id': '102247 (Rota-036)'}, {'id': '106481 (Rota-054)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HRV Group', 'description': 'Subjects who had received 2 doses of HRV vaccine in previous studies.', 'interventionNames': ['Procedure: Serum sample']}, {'label': 'Placebo Group', 'description': 'Subjects who had received 2 doses of placebo in previous studies.', 'interventionNames': ['Procedure: Serum sample']}], 'interventions': [{'name': 'Serum sample', 'type': 'PROCEDURE', 'description': 'Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.', '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'}}}}