ID

29475

Beschrijving

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

Trefwoorden

Versies (2)
  1. 31-03-18 31-03-18 -
  2. 04-04-18 04-04-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

31 maart 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study 103792

Engels

Visit 2

1 Formulieren  
  1. StudyEvent: ODM
    1. Visit 2
Header
Beschrijving

Header

Alias
UMLS CUI-1
C1320722
Subject No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschrijving

DD/MON/YY

Datatype

date

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

Check for Study Continuation

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

subject return for visit 2

Datatype

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.
Beschrijving

If No, please specify

Datatype

integer

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

If Serious adverse event, please specify

Datatype

integer

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

If Non-serious adverse event, please specify

Datatype

integer

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

If Other, please specify

Datatype

text

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

reason for study discontinuation

Datatype

integer

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

Decision

Datatype

text

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

Gastroenteritis Episodes

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

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.

Datatype

boolean

Alias
UMLS CUI [1]
C0017160
Feedings
Beschrijving

Feedings

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

Infant Feeding

Datatype

text

Alias
UMLS CUI [1]
C0420979
Vaccine administration
Beschrijving

Vaccine administration

Alias
UMLS CUI-1
C2368628
Date
Beschrijving

fill in onnly if different from visit date

Datatype

text

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

Pre-Vaccination temperature

Datatype

float

Maateenheden
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Vaccine administration
Beschrijving

Vaccine administration

Datatype

text

Alias
UMLS CUI [1]
C2368628
Replacement vial
Beschrijving

Replacement vial

Datatype

text

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

Wrong vial number

Datatype

text

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

Comments on vaccine administration

Datatype

text

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

fill in only if different from visit date

Datatype

date

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

Please tick the ONE most appropriate category for non administration

Datatype

text

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

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

Datatype

integer

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

number of unsolicited adverse event

Datatype

integer

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

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

Datatype

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?
Beschrijving

regurgitation after oral medication

Datatype

text

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

Decision

Datatype

text

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

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?
Beschrijving

Unsolicited Adverse Events

Datatype

text

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

Visit 2

1 Formulieren
  1. StudyEvent: ODM
    1. Visit 2
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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