ID
32630
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 and when routine vaccine administrations have taken place and should be checked at visits 1-3.
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
Routine Vaccine Administration
- StudyEvent: ODM
Beskrivning
Routine Vaccine Administrations
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C0205547
Beskrivning
If Yes is ticked, the above vaccines are not to be reported again in the Concomitant Vaccination section at the end of the CRF. Any other vaccines administered during the study period are to be recorded in the Concomitant Vaccination section at the end of the CRF.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0032375
Beskrivning
OPV Vaccination Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0032375
- UMLS CUI [1,2]
- C0011008
Beskrivning
If Yes is ticked, the above vaccines are not to be reported again in the Concomitant Vaccination section at the end of the CRF. Any other vaccines administered during the study period are to be recorded in the Concomitant Vaccination section at the end of the CRF.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2240392
- UMLS CUI [1,2]
- C3653328
- UMLS CUI [1,3]
- C0012559
Beskrivning
DTPw-HB/Hib vaccination Date
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2240392
- UMLS CUI [1,2]
- C3653328
- UMLS CUI [1,3]
- C0012559
- UMLS CUI [1,4]
- C1115436
Similar models
Routine Vaccine Administration
- StudyEvent: ODM
C0205547 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C3653328 (UMLS CUI [1,2])
C0012559 (UMLS CUI [1,3])
C3653328 (UMLS CUI [1,2])
C0012559 (UMLS CUI [1,3])
C1115436 (UMLS CUI [1,4])