ID
32436
Beschrijving
Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about testing the subject for HIV. It should be checked at Visit 3 and is part of study amendment 1.
Link
https://clinicaltrials.gov/ct2/show/NCT00241644
Trefwoorden
Versies (1)
- 01-11-18 01-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
1 november 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644
HIV Testing
- StudyEvent: ODM
Beschrijving
HIV Testing
Alias
- UMLS CUI-1
- C1321876
Beschrijving
Medical History for HIV exposure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0019682
- UMLS CUI [1,3]
- C0332157
Beschrijving
Informed Consent Addendum for HIV Testing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0459958
Beschrijving
If the subject has previously signed informed consent
Datatype
date
Alias
- UMLS CUI [1]
- C2985782
Beschrijving
If bloodsample had been taken
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
If bloodsample had been taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
If bloodsample had been taken
Datatype
text
Alias
- UMLS CUI [1]
- C0014441
Beschrijving
Subjects testet positive need a confirmatory test at visit 4, if HIV asymptomatic up to visit 4.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0032520
- UMLS CUI [1,2]
- C1274040
Similar models
HIV Testing
- StudyEvent: ODM
C0019682 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
C0459958 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])