ID

41659

Description

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Screening) is to be filled out at Visit 1 (Day -28 to day 0). Informed Consent has to be obtained prior to any study procedure.

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Keywords

  1. 12/1/20 12/1/20 -
  2. 12/5/20 12/5/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 5, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

Screening

  1. StudyEvent: ODM
    1. Screening
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Centre number
Description

Centre number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Treatment number
Description

Treatment number

Data type

text

Alias
UMLS CUI [1]
C1522541
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
I certify that Informed Consent has been obtained prior to any study procedure.
Description

Informed Consent obtained prior to study

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2347804
Informed Consent Date
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race: African / African American
Description

Race: African / African American

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
Race: American Indian or Alaskan Native
Description

Race: American Indian or Alaskan Native

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Race: Asian - Central/South Asian Heritage
Description

Race: Asian - Central/South Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Race: Asian - East Asian Heritage
Description

Race: Asian - East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C4540996
Race: Asian - Japanese Heritage
Description

Race: Asian - Japanese Heritage

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Race: Asian - South East Asian Heritage
Description

Race: Asian - South East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Race: Native Hawaiian or Other Pacific Islander
Description

Race: Native Hawaiian or Other Pacific Islander

Data type

boolean

Alias
UMLS CUI [1]
C1513907
Race: White - Arabic / North African Heritage
Description

Race: White - Arabic / North African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C2698217
Race: White - Caucasian / European Heritage
Description

Race: White - Caucasian / European Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0043157
Other Race, specify
Description

Other Race

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394

Similar models

Screening

  1. StudyEvent: ODM
    1. Screening
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Treatment number
Item
Treatment number
text
C1522541 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent obtained prior to study
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Informed Consent Date
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Race: African / African American
Item
Race: African / African American
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
Race: American Indian or Alaskan Native
Item
Race: American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Race: Asian - Central/South Asian Heritage
Item
Race: Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Race: Asian - East Asian Heritage
Item
Race: Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Race: Asian - Japanese Heritage
Item
Race: Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Race: Asian - South East Asian Heritage
Item
Race: Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Race: Native Hawaiian or Other Pacific Islander
Item
Race: Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
Race: White - Arabic / North African Heritage
Item
Race: White - Arabic / North African Heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2])
Race: White - Caucasian / European Heritage
Item
Race: White - Caucasian / European Heritage
boolean
C0043157 (UMLS CUI [1])
Other Race
Item
Other Race, specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial