Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-05-10 @ 6:52 AM
Study NCT ID:
NCT01571505
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2012-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D013182', 'term': 'Sprue, Tropical'}], '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'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000375', 'term': 'Aging'}], 'ancestors': [{'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-30', 'studyFirstSubmitDate': '2012-03-28', 'studyFirstSubmitQcDate': '2012-04-03', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.', 'timeFrame': 'Birth to one year', 'description': 'Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.'}], 'secondaryOutcomes': [{'measure': 'Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).', 'timeFrame': 'Birth to one year'}, {'measure': 'Mucosal immune responses (shedding OPV vaccine virus) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).', 'timeFrame': 'Birth to one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oral vaccines', 'Vaccine Responsiveness', 'Tropical Enteropathy'], 'conditions': ['Poliomyelitis', 'Tropical Enteropathy']}, 'referencesModule': {'references': [{'pmid': '28194449', 'type': 'RESULT', 'citation': 'Kanungo S, Kim DR, Haldar B, Snider C, Nalavade U, Kim SA, Park JY, Sinha A, Mallick AH, Manna B, Sur D, Nandy RK, Deshpande JM, Czerkinsky C, Wierzba TF, Petri WA Jr, Ali M, Dey A. Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial. Heliyon. 2017 Jan 9;3(1):e00223. doi: 10.1016/j.heliyon.2016.e00223. eCollection 2017 Jan.'}]}, 'descriptionModule': {'briefSummary': 'Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.', 'detailedDescription': 'Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '49 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Mother willing to sign informed consent form.\n2. Infant aged 0 to 49 days old.\n3. No obvious congenital abnormalities or birth defects.\n\nExclusion Criteria:\n\n1. Parents are not willing to have child's blood drawn.\n2. Parents are planning to enroll child into another clinical study during the time period of this trial.\n3. Mother not willing to have blood drawn and breast milk extracted.\n4. Parents not willing to have field research assistant in home.\n5. History of seizures or other apparent neurologic disorders.\n6. Infant does not have proof of BCG and OPV since birth by immunization card.\n7. History of acute illness and/or immunocompromised state of the child.\n8. Immunocompromised or chronically ill mother"}, 'identificationModule': {'nctId': 'NCT01571505', 'briefTitle': 'Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)', 'organization': {'class': 'OTHER', 'fullName': 'International Vaccine Institute'}, 'officialTitle': 'Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA', 'orgStudyIdInfo': {'id': 'POLIO ROTA-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPV vaccination', 'description': 'Randomized IPV vaccination to children at the age of 39 weeks.', 'interventionNames': ['Biological: IPV vaccination']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'OPV vaccination', 'description': 'Randomized OPV vaccination to children at the age of 39 weeks.', 'interventionNames': ['Biological: IPV vaccination']}], 'interventions': [{'name': 'IPV vaccination', 'type': 'BIOLOGICAL', 'otherNames': ['Rotavirus vaccination to children at 10 and 17 weeks of age.'], 'description': 'Randomized IPV or OPV to children aged at 39weeks.', 'armGroupLabels': ['IPV vaccination', 'OPV vaccination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kolkata', 'country': 'India', 'facility': 'National Institute of Cholera and Enteric Diseases', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}], 'overallOfficials': [{'name': 'Ayan Dey, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Vaccine Institute'}, {'name': 'William Petri, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}, {'name': 'Beth Kirkpatrick, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}, {'name': 'Suman Kanungo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cholera and Enteric Diseases, India'}, {'name': 'Ranjan K Nandy, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cholera and Enteric Diseases, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Vaccine Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'National Institute of Cholera and Enteric Diseases, India', 'class': 'OTHER'}, {'name': 'University of Virginia', 'class': 'OTHER'}, {'name': 'University of Vermont', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}