Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 8:00 AM
Study NCT ID:
NCT00156559
Status:
COMPLETED
Last Update Posted:
2015-09-17
First Post:
2005-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MMR and Varicella Vaccine in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}, {'id': 'D012409', 'term': 'Rubella'}, {'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018355', 'term': 'Rubivirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D019351', 'term': 'Rubulavirus Infections'}, {'id': 'D010309', 'term': 'Parotitis'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-15', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['immunization', 'vaccine', 'low birth weight infant', 'premature infant'], 'conditions': ['Chickenpox', 'Rubella', 'Rubeola', 'Mumps']}, 'referencesModule': {'references': [{'pmid': '17332177', 'type': 'RESULT', 'citation': "D'Angio CT, Boohene PA, Mowrer A, Audet S, Menegus MA, Schmid DS, Beeler JA. Measles-mumps-rubella and varicella vaccine responses in extremely preterm infants. Pediatrics. 2007 Mar;119(3):e574-9. doi: 10.1542/peds.2006-2241."}]}, 'descriptionModule': {'briefSummary': 'This research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at \\<29 weeks gestation, when compared to full-term infants, as measured by the relevant viral serologies.', 'detailedDescription': "Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants\n\nPhase: IV\n\nPopulation: 16 generally healthy premature infants born at \\< 29 weeks' gestation, \\< 16 months old from the Rochester area 16 generally healthy full-term infants born at \\>/= 37 weeks' gestation, \\< 16 months old from the Rochester area\n\nNumber of Sites: University of Rochester\n\nStudy Duration: 1.5 - 8.5 months\n\nDescription of Agent or Intervention:\n\nSubjects will make 2 study visits. The first, at 15 months of age, will coincide with a routine well child visit. Subjects will have 2 mL of blood drawn at the time of their routine, 15-month MMR, varicella, and pneumococcal conjugate immunizations. At a second study visit 4-6 weeks later, another 2 mL of blood will be drawn.\n\nObjectives:\n\nPrimary: We propose to measure the immunogenicity of routinely administered varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at \\<29 weeks gestation (premature), when compared to that in full-term infants.\n\nMeasles titers will be measured by neutralization assay. Mumps and rubella titers will be measured by enzyme-linked florescent immunoassay. Varicella titers will be measured by enzyme linked immunosorbent assay.\n\nSafety will be assessed by parental recall of vaccine-related adverse events and by active, prospective collection of blood-draw-associated adverse events.\n\nSchematic of Study Design:\n\nSubjects will be approached at 9-12 months of age for inclusion, and will consent at this time or at Visit 1\n\nVisit 1 (15 mos):\n\nPreterm N = 16, Full term N = 16, 2 ml blood draw\n\nRoutine MMR, varicella vaccines administered by primary pediatrician per standard of care (at Visit 1)\n\nVisit 2 (16 mos):\n\nPreterm N = 16, Full term N = 16, 2 ml blood draw\n\nVaricella, mumps, measles and rubella vaccine titers measured by ELISA"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects must meet all of the inclusion criteria to participate in this study.\n\n1. Premature infant \\< 29 weeks' gestation at birth or term infant \\>/= 37 weeks' gestation at birth.\n2. Postnatal age \\< 16 months, 0 days.\n3. Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)\n4. Parental permission.\n5. Agreement of primary care pediatrician/ health care provider.\n6. Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.\n7. Healthy status at enrollment.\n\nExclusion Criteria:\n\n1. Known immunodeficiency.\n2. Systemic corticosteroid therapy at the time of MMR/varicella vaccination.\n3. Requiring oxygen therapy.\n4. Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.\n5. Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject."}, 'identificationModule': {'nctId': 'NCT00156559', 'briefTitle': 'MMR and Varicella Vaccine in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'MMR and Varicella Vaccine Responses in Extremely Premature Infants', 'orgStudyIdInfo': {'id': 'DMID 03-140'}, 'secondaryIdInfos': [{'id': 'N01-AI-25460'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': "Carl T. D'Angio, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': "Carl D'Angio", 'investigatorAffiliation': 'University of Rochester'}}}}