ID

36273

Descrição

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

Palavras-chave

Versões (1)
  1. 28/04/2019 28/04/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

28 de abril de 2019

DOI

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Licença

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

Inglês

Visit 3

1 Formulários  
  1. StudyEvent: ODM
    1. Visit 3
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Descrição

Date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descrição

Clinical Trial Subject Unique Identifier

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Descrição

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject come at visit 3?
Descrição

Yes -> Please complete the next pages. No -> Please complete below.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descrição

Continuation status, Clinical Trials, Reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Specify
Descrição

Continuation status, Clinical Trials, Reason

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Please tick who took the decision
Descrição

Continuation status, Clinical Trials, Decision

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
Laboratory Tests - Post-Vaccination Blood Sample
Descrição

Laboratory Tests - Post-Vaccination Blood Sample

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C1443955
Has a blood sample been taken?
Descrição

Collection of blood specimen for laboratory procedure, Post-vaccination precautions

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1443955
Please complete only if different from visit date
Descrição

Collection of blood specimen for laboratory procedure, Post-vaccination precautions, Date in time

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1443955
UMLS CUI [1,3]
C0011008
Gastroenteritis Episodes
Descrição

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
UMLS CUI-2
C0332189
Did the subject present Gastroenteritis anytime starting from day 8 after dose 2 until visit 3?
Descrição

If Yes, please fill the Gastroenteritis section If Yes, please collect a stool sample as soon as possible after Gastroenteritis begins and not later than 7 days after the start of the Gastroenteritis and report the stool collection date in the Gastroenteritis section.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017160
Height / Weight
Descrição

Height / Weight

Alias
UMLS CUI-1
C0005890
UMLS CUI-2
C0005910
Height
Descrição

Body Height

Tipo de dados

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descrição

Body Weight

Tipo de dados

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
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Similar models

Visit 3

1 Formulários
  1. StudyEvent: ODM
    1. Visit 3
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Continuation status, Clinical Trials
Item
Did the subject come at visit 3?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Same reason and decision as previous visit. (1)
CL Item
Serious adverse event (Please specify SAE N°) (2)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (3)
CL Item
Other, please specify (e.g. consent withdrawal, Protocol violation, ...) (4)
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
Specify
Item
Please tick who took the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Decision
Code List
Please tick who took the decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (2)
Item Group
Laboratory Tests - Post-Vaccination Blood Sample
C0005834 (UMLS CUI-1)
C1443955 (UMLS CUI-2)
Collection of blood specimen for laboratory procedure, Post-vaccination precautions
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1,1])
C1443955 (UMLS CUI [1,2])
Collection of blood specimen for laboratory procedure, Post-vaccination precautions, Date in time
Item
Please complete only if different from visit date
date
C0005834 (UMLS CUI [1,1])
C1443955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Gastroenteritis Episodes
C0017160 (UMLS CUI-1)
C0332189 (UMLS CUI-2)
Gastroenteritis
Item
Did the subject present Gastroenteritis anytime starting from day 8 after dose 2 until visit 3?
boolean
C0017160 (UMLS CUI [1])
Item Group
Height / Weight
C0005890 (UMLS CUI-1)
C0005910 (UMLS CUI-2)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
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