Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-08 @ 4:13 AM
Study NCT ID:
NCT03367559
Status:
UNKNOWN
Last Update Posted:
2019-03-25
First Post:
2017-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2017-12-07', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and rate of the AEs within 30 minutes after vaccination', 'timeFrame': '30 minutes after vaccination', 'description': 'Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination'}, {'measure': 'Frequency and rate of the AEs within 7 days after vaccination', 'timeFrame': 'for 7 days after each vaccination', 'description': 'Frequency and rate of adverse effects and severity of solicited adverse events (Local and General) within 7 days after each vaccination'}, {'measure': 'Frequency and rate of the AEs during 28 days after vaccination', 'timeFrame': 'for 28 days after vaccination', 'description': 'Frequency and rate of adverse effects and severity of unsolicited adverse events (Local and General) during 28 days after each vaccination'}, {'measure': 'Frequency and rate of the SAEs during 28 days after vaccination', 'timeFrame': 'for 28 days after vaccination', 'description': 'Frequency and rate of adverse effects and severity of Serious Adverse Events (Local and General) during 28 days after each vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotavirus', 'ROTAVAC', 'Vaccine', 'Vietnam'], 'conditions': ['Rotavirus Infections']}, 'descriptionModule': {'briefSummary': 'An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy infants as established by medical history and clinical examination before entering the study.\n* Age: 6-8 weeks\n* Weight ≥ 2.5kg at birth.\n* Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B)\n* Parental ability and willingness to provide informed consent.\n* Parent who intends to remain in the area with the participant during the study period.\n\nExclusion Criteria:\n\n* Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).\n* Presence of fever (temperature ≥37.5oC) or hypothermia (temperature ≤35.5oC) on the day of enrollment (temporary exclusion).\n* Concurrent participation in another clinical trial.\n* Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the infant's health or is likely to result in non-conformance to the protocol.\n* History of congenital abdominal disorders, intussusception, abdominal surgery\n* Known or suspected impairment of immunological function based on medical history and physical examination.\n* Prior receipt of rotavirus vaccine.\n* A known sensitivity or allergy to any components of the study medication.\n* Major congenital or genetic defect.\n* Participant's parents not able, available or willing to accept active follow-up by the study staff.\n* Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.\n* History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.\n* History of any neurologic disorders or seizures.\n* Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent."}, 'identificationModule': {'nctId': 'NCT03367559', 'briefTitle': 'Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products'}, 'officialTitle': 'An Open Label Study to Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® (Live Attenuated Rotavirus Vaccine) as a 3-dose Series in Healthy Infants Aged Between 6 Weeks and 8 Weeks in Vietnam', 'orgStudyIdInfo': {'id': 'VX-2017.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotavirus Vaccine', 'description': '3 dose, interval for each dose is 4 weeks. The first dose will be received at 6-8 weeks of age.', 'interventionNames': ['Biological: ROTAVAC®']}], 'interventions': [{'name': 'ROTAVAC®', 'type': 'BIOLOGICAL', 'description': 'Rotavac® is in frozen form and is thawed till fully liquid prior to administration.', 'armGroupLabels': ['Rotavirus Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Thái Bình', 'country': 'Vietnam', 'facility': 'Thai Binh Health Center', 'geoPoint': {'lat': 20.45, 'lon': 106.34002}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bharat Biotech International Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pham Ngoc Hung, MD PhD Assoc', 'investigatorAffiliation': 'Vietnam Military Medical University'}}}}