ID
32629
Beskrivning
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 asks if the patient had any episodes of gastroenteritis between visits. It should be checked on visit 2-5. The HIV-Test itemgroup is part of amendment 4.
Länk
https://clinicaltrials.gov/ct2/show/NCT00241644
Nyckelord
Versioner (2)
- 2018-11-01 2018-11-01 -
- 2018-11-09 2018-11-09 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 november 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644
Gastroenteritis Episodes, HIV Testing
- StudyEvent: ODM
Beskrivning
Gastroenteritis Episodes
Alias
- UMLS CUI-1
- C0017160
Beskrivning
HIV Test
Alias
- UMLS CUI-1
- C1321876
Beskrivning
HIV testing should be proposed if a child develops symptoms indicative of AIDS (WHO interim stage III or IV) or has to be hospitalized with SAE, and HIV testing has not yet been performed.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1321876
Similar models
Gastroenteritis Episodes, HIV Testing
- StudyEvent: ODM