ID

36764

Beschreibung

Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT0032362 This form is to be completed at Visit 2.

Link

https://clinicaltrials.gov/ct2/show/NCT0032362

Stichworte

Versionen (2)
  1. 11.12.18 11.12.18 -
  2. 06.06.19 06.06.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

6. Juni 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

Englisch

Visit 2: Demographics, Examination, Malaria control

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

Visit 2, Study month 33 (33 months post dose 1 in Malaria-026; 12 Months after visit 1)

Datentyp

date

Alias
UMLS CUI [1]
C1320303
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
Body weight
Beschreibung

Body weight

Alias
UMLS CUI-1
C0005910
Body weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Beschreibung

Temperature

Alias
UMLS CUI-1
C0005903
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Beschreibung

Route

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Area / Village of residence
Beschreibung

Area / Village of residence

Alias
UMLS CUI-1
C0237096
Geographical area (Bairo)
Beschreibung

Geographical area

Datentyp

integer

Alias
UMLS CUI [1]
C0681784
Bednet usage
Beschreibung

Bednet usage

Alias
UMLS CUI-1
C2717998
Did the subject sleep under a bednet last night?
Beschreibung

Bednet use last night

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2717998
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0240526
Was it an insecticide treated net?
Beschreibung

if applies

Datentyp

boolean

Alias
UMLS CUI [1]
C2717999
Indoor residual spraying
Beschreibung

Indoor residual spraying

Alias
UMLS CUI-1
C0562498
UMLS CUI-2
C2003858
UMLS CUI-3
C1609982
UMLS CUI-4
C0021576
Was the house sprayed?
Beschreibung

Indoor residual spraying of house

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442519
UMLS CUI [1,2]
C0562498
UMLS CUI [1,3]
C2003858
UMLS CUI [1,4]
C1609982
UMLS CUI [1,5]
C0021576
Blood film for prevalence of parasitemia
Beschreibung

Blood film for prevalence of parasitemia

Alias
UMLS CUI-1
C0580670
UMLS CUI-2
C0033105
UMLS CUI-3
C0242723
Has a blood film for prevalence of parasitemia been taken?
Beschreibung

Cohort 1 only from Malaria-026

Datentyp

integer

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0580670
UMLS CUI [1,3]
C0033105
UMLS CUI [1,4]
C0242723
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Ähnliche Modelle

Visit 2: Demographics, Examination, Malaria control

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
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 Group
Body weight
C0005910 (UMLS CUI-1)
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item Group
Temperature
C0005903 (UMLS CUI-1)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
integer
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Oral (1)
CL Item
Axillary (2)
CL Item
Rectal (3)
Item Group
Area / Village of residence
C0237096 (UMLS CUI-1)
Geographical area
Item
Geographical area (Bairo)
integer
C0681784 (UMLS CUI [1])
Item Group
Bednet usage
C2717998 (UMLS CUI-1)
Bednet use last night
Item
Did the subject sleep under a bednet last night?
boolean
C2717998 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0240526 (UMLS CUI [1,3])
insecticide treated net
Item
Was it an insecticide treated net?
boolean
C2717999 (UMLS CUI [1])
Item Group
Indoor residual spraying
C0562498 (UMLS CUI-1)
C2003858 (UMLS CUI-2)
C1609982 (UMLS CUI-3)
C0021576 (UMLS CUI-4)
Indoor residual spraying of house
Item
Was the house sprayed?
boolean
C0442519 (UMLS CUI [1,1])
C0562498 (UMLS CUI [1,2])
C2003858 (UMLS CUI [1,3])
C1609982 (UMLS CUI [1,4])
C0021576 (UMLS CUI [1,5])
Item Group
Blood film for prevalence of parasitemia
C0580670 (UMLS CUI-1)
C0033105 (UMLS CUI-2)
C0242723 (UMLS CUI-3)
Item
Has a blood film for prevalence of parasitemia been taken?
integer
C1277698 (UMLS CUI [1,1])
C0580670 (UMLS CUI [1,2])
C0033105 (UMLS CUI [1,3])
C0242723 (UMLS CUI [1,4])
Has a blood film for prevalence of parasitemia been taken?
Code List
Has a blood film for prevalence of parasitemia been taken?
CL Item
No (1)
CL Item
Yes (2)
CL Item
NA (for Cohort 2) (3)
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