ID

32084

Beschrijving

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is only for documentation of unplanned stool samples in case of gastroenteritis epidoseds during the trial. Planned stool samples at pre-defined timepoints need to be recorded in the "planned stool sample" form for visits 3 and 5.

Link

https://clinicaltrials.gov/ct2/show/NCT00139334

Trefwoorden

  1. 17-10-18 17-10-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

17 oktober 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

Gastroenteritis stools collection

Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Gastroenteritis stools samples
Beschrijving

Gastroenteritis stools samples

Alias
UMLS CUI-1
C0017160
UMLS CUI-2
C1550661
Stool sample number / "Stools [N°]"
Beschrijving

Stool sample number

Datatype

integer

Alias
UMLS CUI [1,1]
C1550661
UMLS CUI [1,2]
C1299222
Date
Beschrijving

Stool sample Date

Datatype

date

Alias
UMLS CUI [1,1]
C1550661
UMLS CUI [1,2]
C0011008
Time
Beschrijving

Stool sample Time

Datatype

time

Alias
UMLS CUI [1,1]
C1550661
UMLS CUI [1,2]
C0040223

Similar models

Gastroenteritis stools collection

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Gastroenteritis stools samples
C0017160 (UMLS CUI-1)
C1550661 (UMLS CUI-2)
Stool sample number
Item
Stool sample number / "Stools [N°]"
integer
C1550661 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
Stool sample Date
Item
Date
date
C1550661 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Stool sample Time
Item
Time
time
C1550661 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])

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