ID

29495

Descrição

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 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 CRF Seiten: 375-430

Palavras-chave

Versões (2)
  1. 31/03/2018 31/03/2018 -
  2. 04/04/2018 04/04/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

4 de abril de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study NCT00289172

Inglês

Visit 2

1 Formulários  
  1. StudyEvent: ODM
    1. Visit 2
Header
Descrição

Header

Alias
UMLS CUI-1
C1320722
Subject No.
Descrição

Subject No.

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Descrição

DD/MON/YY

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Check for Study Continuation
Descrição

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject come at visit 2 ?
Descrição

subject return for visit 2

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descrição

If No, please specify

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
SAE Number
Descrição

If Serious adverse event, please specify

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number or Code
Descrição

If Non-serious adverse event, please specify

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Other reason for Study Discontinuation
Descrição

If Other, please specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
reason for study discontinuation
Descrição

reason for study discontinuation

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Please tick who took decision:
Descrição

Decision

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Gastroenteritis Episodes
Descrição

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
Did the subject present Gastroenteritis anytime starting from 8 days after dose 1 until Dose 2?
Descrição

If Yes, please fill the Gastroenteritis section. 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
Feedings
Descrição

Feedings

Alias
UMLS CUI-1
C0420979
Is the child fed with:
Descrição

Infant Feeding

Tipo de dados

text

Alias
UMLS CUI [1]
C0420979
Vaccine administration
Descrição

Vaccine administration

Alias
UMLS CUI-1
C2368628
Date
Descrição

fill in onnly if different from visit date

Tipo de dados

text

Alias
UMLS CUI [1]
C1115436
Pre-Vaccination temperature
Descrição

Pre-Vaccination temperature

Tipo de dados

float

Unidades de medida
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Vaccine administration
Descrição

Vaccine administration

Tipo de dados

text

Alias
UMLS CUI [1]
C2368628
Replacement vial
Descrição

Replacement vial

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Wrong vial number
Descrição

Wrong vial number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C3827420
Comments (on vaccine administration)
Descrição

Comments on vaccine administration

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Date of vaccination
Descrição

fill in only if different from visit date

Tipo de dados

date

Alias
UMLS CUI [1]
C4301990
Why was the vaccine not administered?
Descrição

Please tick the ONE most appropriate category for non administration

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
SAE No
Descrição

Please specify number of SAE if that is the reason, why vaccine wasn't administered.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Please specify unsolicited AE No
Descrição

number of unsolicited adverse event

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Please specify 'other' most appropriate category for non administration.
Descrição

e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2368628
Regurgitation with in 30 minutes after HRV vaccine or placebo?
Descrição

regurgitation after oral medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C2004489
Please tick who took decision:
Descrição

Decision

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Unsolicited Adverse Events
Descrição

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Descrição

Unsolicited Adverse Events

Tipo de dados

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0042196
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Similar models

Visit 2

1 Formulários
  1. StudyEvent: ODM
    1. Visit 2
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject come at visit 2 ?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject return for visit 2
Code List
Did the subject come at visit 2 ?
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please specify (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse Event (1)
CL Item
Non-Serious adverse Event (2)
CL Item
Other (3)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other reason for Study Discontinuation
Item
Other reason for Study Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for study discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
non administration
Code List
reason for study discontinuation
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item
Please tick who took decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision
Code List
Please tick who took decision:
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
Gastroenteritis Episodes
C0017160 (UMLS CUI-1)
Gastroenteritis
Item
Did the subject present Gastroenteritis anytime starting from 8 days after dose 1 until Dose 2?
boolean
C0017160 (UMLS CUI [1])
Item Group
Feedings
C0420979 (UMLS CUI-1)
Item
Is the child fed with:
text
C0420979 (UMLS CUI [1])
Infant Feeding
Code List
Is the child fed with:
CL Item
Breast Milk (1)
CL Item
Infant Formula (2)
CL Item
Both (3)
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Date of vaccination
Item
Date
text
C1115436 (UMLS CUI [1])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
Study Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial
Item
Replacement vial
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Comments on vaccine administration
Item
Comments (on vaccine administration)
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Date of vaccination
Item
Date of vaccination
date
C4301990 (UMLS CUI [1])
Item
Why was the vaccine not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Why was the vaccine not administered?
Code List
Why was the vaccine not administered?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for non administration.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Item
Regurgitation with in 30 minutes after HRV vaccine or placebo?
text
C0175795 (UMLS CUI [1,1])
C2004489 (UMLS CUI [1,2])
regurgitation after oral medication
Code List
Regurgitation with in 30 minutes after HRV vaccine or placebo?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not administered only (NA)
Item
Please tick who took decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision
Code List
Please tick who took decision:
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
C0877248 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
Unsolicited Adverse Events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (U)
CL Item
No vaccine administered  (NA)
CL Item
No (N)
CL Item
Yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. (Y)
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