ID
36260
Description
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
Keywords
Versions (1)
- 4/25/19 4/25/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 25, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
GSK Biologicals' oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants; NCT00289172
Study Conclusion
- StudyEvent: ODM
Description
Occurrence of Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event, Count of entities
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Description
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Description
Subject Unblinding Event Record
Data type
boolean
Alias
- UMLS CUI [1]
- C3897431
Description
Subject Unblinding Event Record, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
Subject Unblinding Event Record, Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Description
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Withdraw
Alias
- UMLS CUI-1
- C2349954
Description
Withdraw
Data type
boolean
Alias
- UMLS CUI [1]
- C2349954
Description
Withdraw, Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Description
Withdraw, Indication, Details
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Description
Withdraw, Date last contact
Data type
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
Description
Withdraw, Date last contact, General physical condition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
- UMLS CUI [1,3]
- C1142435
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator Name
Data type
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])