ID
36260
Beskrivning
Study ID: 103792 Clinical Study ID: 103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus
Nyckelord
Versioner (1)
- 2019-04-25 2019-04-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
25 april 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK Biologicals' oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants; NCT00289172
Study Conclusion
- StudyEvent: ODM
Beskrivning
Occurrence of Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Serious Adverse Event, Count of entities
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beskrivning
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beskrivning
Subject Unblinding Event Record
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3897431
Beskrivning
Subject Unblinding Event Record, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beskrivning
Subject Unblinding Event Record, Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beskrivning
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Withdraw
Alias
- UMLS CUI-1
- C2349954
Beskrivning
Withdraw
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2349954
Beskrivning
Withdraw, Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Beskrivning
Withdraw, Indication, Details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Beskrivning
Withdraw, Date last contact
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
Beskrivning
Withdraw, Date last contact, General physical condition
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
- UMLS CUI [1,3]
- C1142435
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator Signature, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Study Conclusion
- StudyEvent: ODM
C0449788 (UMLS CUI [1,2])
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0805839 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])