ID

36258

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)
  1. 4/25/19 4/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 25, 2019

DOI

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License

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

English

Concomitant Vaccination

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0042196
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Description

If Yes, please record concomitant vaccination with trade name and / or generic name, route and vaccine administration date.

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0042196
Trade / (Generic) Name
Description

Concomitant Agent, Vaccination, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C2360065
Route
Description

Concomitant Agent, Vaccination, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0013153
Administration date
Description

Concomitant Agent, Vaccination, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0011008
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Similar models

Concomitant Vaccination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C2347852 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Concomitant Agent, Vaccination
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Concomitant Agent, Vaccination, Medication name
Item
Trade / (Generic) Name
text
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Concomitant Agent, Vaccination, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Concomitant Agent, Vaccination, Date in time
Item
Administration date
date
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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