ID

41659

Beschreibung

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

Stichworte

Versionen (2)
  1. 01.12.20 01.12.20 -
  2. 05.12.20 05.12.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Dezember 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

Englisch

Screening

1 Formulare  
  1. StudyEvent: ODM
    1. Screening
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Centre number
Beschreibung

Centre number

Datentyp

text

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

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Treatment number
Beschreibung

Treatment number

Datentyp

text

Alias
UMLS CUI [1]
C1522541
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Beschreibung

Informed Consent

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

Informed Consent obtained prior to study

Datentyp

boolean

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

Informed Consent Date

Datentyp

date

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

Demographics

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

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

Race: African / African American

Datentyp

boolean

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

Race: American Indian or Alaskan Native

Datentyp

boolean

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

Race: Asian - Central/South Asian Heritage

Datentyp

boolean

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

Race: Asian - East Asian Heritage

Datentyp

boolean

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

Race: Asian - Japanese Heritage

Datentyp

boolean

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

Race: Asian - South East Asian Heritage

Datentyp

boolean

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

Race: Native Hawaiian or Other Pacific Islander

Datentyp

boolean

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

Race: White - Arabic / North African Heritage

Datentyp

boolean

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

Race: White - Caucasian / European Heritage

Datentyp

boolean

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

Other Race

Datentyp

text

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

Screening

1 Formulare
  1. StudyEvent: ODM
    1. Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
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])
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