ID

33519

Description

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

Keywords

  1. 12/11/18 12/11/18 -
  2. 6/6/19 6/6/19 -
Copyright Holder

GSK group of companies

Uploaded on

December 11, 2018

DOI

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License

Creative Commons BY-NC 3.0

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Immunogenicity of malaria vaccine candidate in Mozambican children (1 to 4 y.o) - 104297 (Malaria039)

Visit 2: Demographics

  1. StudyEvent: ODM
    1. Visit 2: Demographics
Administrative data
Description

Administrative data

Protocol Number
Description

Protocol Number

Data type

integer

Subject Number
Description

Subject Number

Data type

integer

Date of Visit
Description

Date of Visit

Data type

date

Visit
Description

Visit

Data type

text

Demographics
Description

Demographics

Date of birth
Description

Date of birth

Data type

date

Gender
Description

Gender

Data type

text

Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
kg
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Route
Description

Route

Data type

text

Area / Village of residence
Description

Area / Village of residence

Geographical area (Bairo)
Description

Geographical area (Bairo)

Data type

integer

Bednet usage
Description

Bednet usage

Did the subject sleep under a bednet last night?
Description

Did the subject sleep under a bednet last night?

Data type

boolean

Was it an insecticide treated net?
Description

if applies

Data type

boolean

Indoor residual spraying
Description

Indoor residual spraying

Was the house sprayed?
Description

Was the house sprayed?

Data type

boolean

Blood film for prevalence of parasitemia
Description

Blood film for prevalence of parasitemia

Has a blood film for prevalence of parasitemia been taken?
Description

Cohort 1 only from Malaria-026

Data type

integer

Similar models

Visit 2: Demographics

  1. StudyEvent: ODM
    1. Visit 2: Demographics
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Protocol Number
Item
Protocol Number
integer
Subject Number
Item
Subject Number
integer
Date of Visit
Item
Date of Visit
date
Item
Visit
text
Code List
Visit
CL Item
Visit 2, Study month 33 (33 months post dose 1 in Malaria-026; 12 Months after visit 1) (1)
Item Group
Demographics
Date of birth
Item
Date of birth
date
Item
Gender
text
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Body weight
Item
Body weight
float
Temperature
Item
Temperature
float
Item
Route
text
Code List
Route
CL Item
Oral (1)
CL Item
Axillary (2)
CL Item
Rectal (3)
Item Group
Area / Village of residence
Geographical area (Bairo)
Item
Geographical area (Bairo)
integer
Item Group
Bednet usage
Did the subject sleep under a bednet last night?
Item
Did the subject sleep under a bednet last night?
boolean
Was it an insecticide treated net?
Item
Was it an insecticide treated net?
boolean
Item Group
Indoor residual spraying
Was the house sprayed?
Item
Was the house sprayed?
boolean
Item Group
Blood film for prevalence of parasitemia
Item
Has a blood film for prevalence of parasitemia been taken?
integer
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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