ID

29761

Description

https://clinicaltrials.gov/show/NCT00197028 Concomitant vaccination and medication Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

Link

https://clinicaltrials.gov/show/NCT00197028

Keywords

Versions (1)
  1. 4/18/18 4/18/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

April 18, 2018

DOI

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License

Creative Commons BY-NC 3.0
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RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028

English

Concomitant vaccination and medication

1 forms  
Concomitan vaccination
Description

Concomitan vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered before Clinic Visit 10 (Interim Analysis)?
Description

Concomitan vaccination

Data type

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Trade / (Generic) Name
Description

Vaccine name

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0042210
Route
Description

Vaccination route

Data type

text

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

Vaccine administration date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C2347852
Have any medications/treatments been administered before Clinic Visit 10 (Interim Analysis)?
Description

Medication

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Trade / Generic Name
Description

Trade / Generic Name

Data type

text

Alias
UMLS CUI [1]
C2360065
Medical Indication: Prophylactic
Description

Medical Indication

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Medical Indication:
Description

Medical Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total daily Dose
Description

Total daily Dose

Data type

text

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

Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Start and end date
Description

Start and end date

Data type

date

Alias
UMLS CUI [1]
C3844769
Tick box if continuing at end of study
Description

Tick box if continuing at end of study

Data type

boolean

Alias
UMLS CUI [1]
C2826666
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Similar models

Concomitant vaccination and medication

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitan vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered before Clinic Visit 10 (Interim Analysis)?
integer
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitan vaccination
Code List
Has any vaccine other than the study vaccine(s) been administered before Clinic Visit 10 (Interim Analysis)?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date. (2)
Vaccine name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccination route
Code List
Route
CL Item
Intradermal  (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation  (IH)
CL Item
Oral (PO)
CL Item
Intramuscular (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous  (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal  (NA)
CL Item
Transdermal (TD)
CL Item
Other  (OTH)
CL Item
Unknown (UNK)
Vaccine administration date
Item
Administration date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item Group
Medication
C0013227 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Have any medications/treatments been administered before Clinic Visit 10 (Interim Analysis)?
integer
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medication
Code List
Have any medications/treatments been administered before Clinic Visit 10 (Interim Analysis)?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Trade / Generic Name
Item
Trade / Generic Name
text
C2360065 (UMLS CUI [1])
Medical Indication
Item
Medical Indication: Prophylactic
boolean
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Item
Medical Indication:
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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])
Route
Code List
Route
CL Item
EXT External (EXT External)
CL Item
ID Intradermal (ID Intradermal)
CL Item
IH Inhalation (IH Inhalation)
CL Item
IM Intramuscular (IM Intramuscular)
CL Item
IR Intraarticular (IR Intraarticular)
CL Item
IT Intrathecal (IT Intrathecal)
CL Item
IV Intravenous (IV Intravenous)
CL Item
NA Intranasal (NA Intranasal)
CL Item
OTH Other (OTH Other)
CL Item
PE Parenteral (PE Parenteral)
CL Item
PO Oral (PO Oral)
CL Item
PR Rectal (PR Rectal)
CL Item
SC Subcutaneous (SC Subcutaneous)
CL Item
SL Sublingual (SL Sublingual)
CL Item
TD Transdermal (TD Transdermal)
CL Item
TO Topical (TO Topical)
CL Item
UNK Unknown (UNK Unknown)
Start and end date
Item
Start and end date
date
C3844769 (UMLS CUI [1])
Tick box if continuing at end of study
Item
Tick box if continuing at end of study
boolean
C2826666 (UMLS CUI [1])
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