Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-01-22 @ 9:12 AM
Study NCT ID:
NCT01870206
Status:
UNKNOWN
Last Update Posted:
2013-09-30
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Poliovirus Excretion', 'timeFrame': 'Evaluate viral excretion rate, basal 7, 14, 21 and 28 days after vaccination of two vaccines against polio OPV in newborns Mexicans'}], 'primaryOutcomes': [{'measure': 'Change seroconversion after one dose of trivalent vaccine OPV', 'timeFrame': 'after the first dose is taken blood samples (baseline, 30 and 60 days)'}], 'secondaryOutcomes': [{'measure': 'Evaluate the adverse events in newborns babies', 'timeFrame': 'inmediately after treatment and during 60 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immunogenicity', 'Safety', 'Efficacy', 'Poliomyelitis', 'Newborn'], 'conditions': ['Poliomyelitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.birmex.gob.mx', 'label': 'Laboratorios de Biológicos y Reactivos de México S.A de C.V'}]}, 'descriptionModule': {'briefSummary': 'Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. There is no cure for polio, it can only be prevented. Polio vaccine, given multiple times, can protect a child for life.\n\nCompare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.', 'detailedDescription': 'This is a randomized clinical trial, which includes 320 newborns of both sexes and residents of the state of México, 160 newborns receive the vaccine OPV Birmex and 160 newborns receive the vaccine OPV Sanofi Pasteur'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Weeks', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns babies\n* Weight ≥ 2.5 kg\n* Have not received any doses of Polio Vaccine\n* Whose parents or guardians reside in the work area\n* Whose parent or guardian accept to sign written informed consent (by the other, father or guardian).\n\nExclusion Criteria:\n\n* Born of a high-risk pregnancy.\n* Weight ≤ 2.5 kg\n* Presence of fever, diarrhea, known immunosuppression, respiratory infections.\n* Treatment with immunosuppressants.\n* Having neurological diseases.\n* Require or received surgery in oropharynx.'}, 'identificationModule': {'nctId': 'NCT01870206', 'briefTitle': 'Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns', 'organization': {'class': 'OTHER', 'fullName': 'Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.'}, 'officialTitle': 'Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans', 'orgStudyIdInfo': {'id': 'Birmex-ECA-01-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trivalent OPV Birmex', 'description': 'Newborns receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine. A second dose four weeks after the first application.', 'interventionNames': ['Biological: Trivalent OPV Birmex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trivalent OPV Sanofi Pasteur', 'description': 'Newborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine. A second dose four weeks after the first application.', 'interventionNames': ['Biological: Trivalent OPV Sanofi Pasteur']}], 'interventions': [{'name': 'Trivalent OPV Birmex', 'type': 'BIOLOGICAL', 'otherNames': ['tOPV'], 'description': 'Newborns who receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.', 'armGroupLabels': ['Trivalent OPV Birmex']}, {'name': 'Trivalent OPV Sanofi Pasteur', 'type': 'BIOLOGICAL', 'otherNames': ['tOPV'], 'description': 'Newborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.', 'armGroupLabels': ['Trivalent OPV Sanofi Pasteur']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56613', 'city': 'Valle de Chalco', 'state': 'State of Mexico', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Monserrat Ávila-Flores, Pediatrics', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General de Chalco Dr. Fernando Quiroz Gutierrez', 'geoPoint': {'lat': 19.30045, 'lon': -98.93944}}], 'centralContacts': [{'name': 'Alvaro García-Pérez, MD', 'role': 'CONTACT', 'email': 'agarciap@birmex.gob.mx', 'phone': '5554222840', 'phoneExt': '139'}], 'overallOfficials': [{'name': 'Mauricio Rodríguez Álvarez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratorios de Biológicos y Reactivos de México S.A de C.V'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}