ID

29703

Beschreibung

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

Stichworte

Versionen (1)
  1. 13.04.18 13.04.18 -
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GlaxoSmithKline

Hochgeladen am

13. April 2018

DOI

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Rotavirus Vaccine RIX4414 Study NCT00289172

Deutsch Englisch

gastroenteritis, concomitant vaccination, medication and non-serious adverse events

1 Formulare  
Header
Beschreibung

Header

Alias
UMLS CUI-1
C1320722
Subject Number:
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Gastroenteritis Episodes
Beschreibung

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
Episode Number
Beschreibung

Gastroenteritis Episode

Datentyp

integer

Alias
UMLS CUI [1,1]
C0017160
UMLS CUI [1,2]
C0332189
Medical advice?
Beschreibung

Medical advice

Datentyp

boolean

Alias
UMLS CUI [1]
C1386497
Type - Medical advice
Beschreibung

Type - Medical advice

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C1386497
First stool collection day and time
Beschreibung

Stool collection time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0015733
UMLS CUI [1,2]
C4064021
Second stool collection day and time
Beschreibung

Stool collection time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0015733
UMLS CUI [1,2]
C4064021
Medication for diarrhea
Beschreibung

Medication for diarrhea

Datentyp

text

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C0087111
Gastroenteritis Protocol
Beschreibung

Gastroenteritis Protocol

Alias
UMLS CUI-1
C0017160
Date
Beschreibung

date of gastroenteritis episode

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Number of looser than normal stools per day
Beschreibung

loose stool count

Datentyp

integer

Alias
UMLS CUI [1,1]
C2129214
UMLS CUI [1,2]
C1265611
Number of episodes of vomiting per day
Beschreibung

vomiting count

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C1265611
Body Temperature
Beschreibung

Body Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Not taken (Temperature)
Beschreibung

Temperature not taken

Datentyp

boolean

Alias
UMLS CUI [1]
C0039476
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol ?
Beschreibung

Concomitant vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade/Generic Name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Beschreibung

Administration date

Datentyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Medication
Beschreibung

Medication

Have any medications/treatments been administered during study period?
Beschreibung

Medication

Datentyp

integer

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0087111
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
Trade or generic name
Beschreibung

Medication name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Beschreibung

Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Medical Indication: Prophylactic?
Beschreibung

Prophylactic

Datentyp

boolean

Alias
UMLS CUI [1]
C0199176
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013227
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Route
Beschreibung

Administration Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Beschreibung

Medication End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Ongoing: tick box if continuing at end of study
Beschreibung

Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Non-serious Adverse Events
Beschreibung

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0042210
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschreibung

If YES, please complete the following table.

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Adverse Event Number
Beschreibung

Adverse Event Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-serious adverse events: Description
Beschreibung

Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Non-serious adverse events: Description
Beschreibung

Description

Datentyp

integer

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Type of vaccine
Beschreibung

Description of Non-Serious Adverse Event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0678257
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Start: during immediate post-vaccination period (30 minutes)
Beschreibung

Start

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C1518404
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Beschreibung

Relationship to investigational product(s)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Medically attended visit?
Beschreibung

Medically attended visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C1518404
Medically attended visit type
Beschreibung

Did the subject seek medical advice? If yes, please specify type

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C1518404
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Ähnliche Modelle

gastroenteritis, concomitant vaccination, medication and non-serious adverse events

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number:
integer
C2348585 (UMLS CUI [1])
Item Group
Gastroenteritis Episodes
C0017160 (UMLS CUI-1)
Gastroenteritis Episode
Item
Episode Number
integer
C0017160 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type - Medical advice
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Type - Medical advice
Code List
Type - Medical advice
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Stool collection time
Item
First stool collection day and time
datetime
C0015733 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Stool collection time
Item
Second stool collection day and time
datetime
C0015733 (UMLS CUI [1,1])
C4064021 (UMLS CUI [1,2])
Item
Medication for diarrhea
text
C0011991 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Medication for diarrhea
Code List
Medication for diarrhea
CL Item
Oral rehydration (1)
CL Item
IV rehydration (2)
CL Item
Oral and IV rehydration (3)
CL Item
No medication (4)
CL Item
Other, please specify (5)
Item Group
Gastroenteritis Protocol
C0017160 (UMLS CUI-1)
date of gastroenteritis episode
Item
Date
date
C0011008 (UMLS CUI [1])
loose stool count
Item
Number of looser than normal stools per day
integer
C2129214 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
vomiting count
Item
Number of episodes of vomiting per day
integer
C0042963 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
Temperature not taken
Item
Not taken (Temperature)
boolean
C0039476 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Concomitant vaccination
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol ?
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Name
Item
Trade/Generic Name
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Item
Have any medications/treatments been administered during study period?
integer
C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Medication
Code List
Have any medications/treatments been administered during study period?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Item Group
Medication
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Medication name
Item
Trade or generic name
text
C2360065 (UMLS CUI [1])
Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
Medical Indication: Prophylactic?
boolean
C0199176 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Administration Route
Code List
Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing: tick box if continuing at end of study
boolean
C2826666 (UMLS CUI [1])
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
integer
C1518404 (UMLS CUI [1])
Withdrawal
Code List
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (1)
CL Item
Yes, please complete the following table (2)
Adverse Event Number
Item
Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Non-serious adverse events: Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-serious adverse events: Description
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Description
Code List
Non-serious adverse events: Description
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Item
Type of vaccine
integer
C0042210 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
undefined item
Code List
Type of vaccine
CL Item
Tritanrix-HepB/Hib-MenAC vaccine (1)
CL Item
Tritanrix-HepB/Hiberix vaccine (2)
CL Item
Meningitec vaccine (3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start
Item
Start: during immediate post-vaccination period (30 minutes)
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Modearte (2)
CL Item
Severe (3)
Relationship to investigational product(s)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Item
Medically attended visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2])
Medical advice type
Code List
Medically attended visit type
CL Item
Hospitalisation (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
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