ID

32082

Beschreibung

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 for documentation of gastroenteritis episodes between visits 3 and 4, 4 and 5 as well as 5 and 6, starting 1 week after dose 1 of HRV/Placebo in Visit 3). To be assessed at Visits 4, 5 and 6. Visit 4 -> Timing: Day 60, Age: 14 weeks +/- 1 week Visit 5 -> Timing: Day 75, Age: 16 weeks +/- 1 week Visit 6 -> Timing: Day 105, Age: 20 weeks +/- 1 week

Link

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

Stichworte

  1. 17.10.18 17.10.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. Oktober 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0

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

Gastroenteritis episodes

Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit number
Beschreibung

Visit number

Datentyp

integer

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
UMLS CUI [1]
C1549755
Gastroenteritis episodes
Beschreibung

Gastroenteritis episodes

Alias
UMLS CUI-1
C0017160
Did the subject present diarrhea during the period between this and the preceeding visit (starting from 1 week after Dose 1 or 2 for Visits 4 and 6)?
Beschreibung

if yes: please collect a stool sample and report the stools collection date in the gastroenteritis stool collection section. Please fill in the Non-Serious AE or the SAE form.

Datentyp

boolean

Alias
UMLS CUI [1]
C0017160

Ähnliche Modelle

Gastroenteritis episodes

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
integer
C25337 (NCI Thesaurus ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI [1])
Code List
Visit number
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
Item Group
Gastroenteritis episodes
C0017160 (UMLS CUI-1)
Gastroenteritis episodes
Item
Did the subject present diarrhea during the period between this and the preceeding visit (starting from 1 week after Dose 1 or 2 for Visits 4 and 6)?
boolean
C0017160 (UMLS CUI [1])

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