Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01700127
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2012-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007774', 'term': 'Lactation'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D049590', 'term': 'Postpartum Period'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2012-09-28', 'studyFirstSubmitQcDate': '2012-10-03', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Concentration of anti-VP6 antibodies in subjects and maternal serum at baseline and in subjects 4 weeks after the second dose of Rotarix®. Geometric mean titers of anti-VP6 IgG antibodies in maternal serum at baseline', 'timeFrame': 'upto 14-18 weeks of age'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®.', 'timeFrame': '14-18 weeks of age'}], 'secondaryOutcomes': [{'measure': 'Concentration of anti-VP6 antibodies in saliva of subjects before the first and second dose of Rotarix®. Proportion of subjects with enteric pathogens detected in stools. Vitamin D status of subjects enrolled in the study.', 'timeFrame': '14-18 weeks of age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['immune response', 'infants', 'rotavirus vaccine'], 'conditions': ['Innate Immune Response']}, 'referencesModule': {'references': [{'pmid': '25091668', 'type': 'DERIVED', 'citation': 'Rongsen-Chandola T, Strand TA, Goyal N, Flem E, Rathore SS, Arya A, Winje BA, Lazarus R, Shanmugasundaram E, Babji S, Sommerfelt H, Vainio K, Kang G, Bhandari N. Effect of withholding breastfeeding on the immune response to a live oral rotavirus vaccine in North Indian infants. Vaccine. 2014 Aug 11;32 Suppl 1:A134-9. doi: 10.1016/j.vaccine.2014.04.078.'}, {'pmid': '24976452', 'type': 'DERIVED', 'citation': 'Rongsen-Chandola T, Winje BA, Goyal N, Rathore SS, Mahesh M, Ranjan R, Arya A, Rafiqi FA, Bhandari N, Strand TA. Compliance of mothers following recommendations to breastfeed or withhold breast milk during rotavirus vaccination in North India: a randomized clinical trial. Trials. 2014 Jun 28;15:256. doi: 10.1186/1745-6215-15-256.'}]}, 'descriptionModule': {'briefSummary': 'This will be a randomized study with the primary objective of assessing the impact of withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.\n\nEnrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14 weeks. The subjects will be randomized into one of the two study arms. In one of the group caregivers will be advised to breastfeed immediately prior to and after each dose of the vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30 minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.', 'detailedDescription': 'Infants ≤7 weeks and pregnant women will be identified through a household survey.Families of infants aged 6-7 weeks will be called to the study clinic for consenting, screening and enrollment.All enrolled subjects will be administered 2 doses of Rotarix® at 6 to 7 weeks and at 10-14 weeks of age. Other childhood vaccines will also be offered.\n\nAt enrollment, a blood specimen and breast milk specimen will be obtained from the mother and a blood, salivary and stool specimens will be obtained from the subject before administering the Rotarix® vaccine.\n\nAt the time of the 2nd administration, a breast milk specimen will be obtained from the mother and a salivary specimen will be obtained from the subject before administering the Rotarix® vaccine. At 28 days (±) 5 after the 2nd dose of Rotarix® vaccine, a blood, salivary and stool specimen will be obtained from the subject.\n\nWhenever the family comes to the study clinic at 6-7 weeks, consent will be administered and a clinical examination conducted.If the family is willing for the mother and the child to be part of the study and the child meets the eligibility criteria, the child will be enrolled.\n\nDepending on the group allocation the mothers will be advised to withhold or encourage breastfeeding for 30 minutes before and after receipt of Rotarix®.\n\nsubjects will be observed for 30 minutes after receipt of the vaccines to assess for immediate adverse events.\n\nAll minor illnesses that do not require hospital referral will be managed by the study physician using current practices.\n\nAll hospitalizations and deaths will be reported and reviewed by an Independent Safety Monitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures\n2. Subjects aged 6 to 7 weeks at recruitment\n3. No plans to move in the next 4 months\n4. Weight for age not ≤ -3 SD of WHO child growth standards\n\nExclusion Criteria:\n\n1. Infant not breastfed\n2. Administration of rotavirus vaccine in the past\n3. Known immunodeficiency disease, including HIV infection in the subject or the mother\n4. Known chronic enteric disease\n5. Diarrhea on the day of enrollment (temporary exclusion)\n6. Any illness requiring hospitalization (temporary exclusion)\n7. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)"}, 'identificationModule': {'nctId': 'NCT01700127', 'acronym': 'PPIR', 'briefTitle': 'Predictors of Poor Immune Response to Rotavirus Vaccine in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Society for Applied Studies'}, 'officialTitle': 'Predictors of Poor Immune Response to Rotavirus Vaccine in Infants', 'orgStudyIdInfo': {'id': 'SAS/RCN/201208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Breastfeeding', 'description': 'Breastfeeding Encouraged', 'interventionNames': ['Other: Breastfeeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Breastfeeding Withheld', 'description': 'Breastfeeding Withheld', 'interventionNames': ['Other: Breastfeeding']}], 'interventions': [{'name': 'Breastfeeding', 'type': 'OTHER', 'description': 'breastfeeding encouraged versus withheld', 'armGroupLabels': ['Breastfeeding', 'Breastfeeding Withheld']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Centre for Health Research and Development Society for Applied Studies', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Temsunaro R Chandola, MBBS MSc Epi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Scientist, SAS'}, {'name': 'Nita Bhandari, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joint Director, SAS'}, {'name': 'Sunita Taneja, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Coordinator, SAS'}, {'name': 'Gagandeep Kang, MD PhD FRCPath', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor and Head,The Wellcome Trust Research Laboratory,Christian Medical College'}, {'name': 'Tor A Strand, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adjunct Professor, CIH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Society for Applied Studies', 'class': 'OTHER'}, 'collaborators': [{'name': 'Christian Medical College, Vellore, India', 'class': 'OTHER'}, {'name': 'Norwegian Institute of Public Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}