ID
36260
Beschrijving
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
Trefwoorden
Versies (1)
- 25-04-19 25-04-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 april 2019
DOI
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Licentie
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
Beschrijving
Occurrence of Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Serious Adverse Event, Count of entities
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beschrijving
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschrijving
Subject Unblinding Event Record
Datatype
boolean
Alias
- UMLS CUI [1]
- C3897431
Beschrijving
Subject Unblinding Event Record, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschrijving
Subject Unblinding Event Record, Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beschrijving
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Withdraw
Alias
- UMLS CUI-1
- C2349954
Beschrijving
Withdraw
Datatype
boolean
Alias
- UMLS CUI [1]
- C2349954
Beschrijving
Withdraw, Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Beschrijving
Withdraw, Indication, Details
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Beschrijving
Withdraw, Date last contact
Datatype
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
Beschrijving
Withdraw, Date last contact, General physical condition
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
- UMLS CUI [1,3]
- C1142435
Beschrijving
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator Signature, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Investigator Name
Datatype
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])