ID

36764

Beschrijving

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

Trefwoorden

Versies (2)
  1. 11-12-18 11-12-18 -
  2. 06-06-19 06-06-19 -
Houder van rechten

GSK group of companies

Geüploaded op

6 juni 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

Engels

Visit 2: Demographics, Examination, Malaria control

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschrijving

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

Datatype

date

Alias
UMLS CUI [1]
C1320303
Demographics
Beschrijving

Demographics

Alias
UMLS CUI-1
C0011298
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschrijving

Gender

Datatype

text

Alias
UMLS CUI [1]
C0079399
Body weight
Beschrijving

Body weight

Alias
UMLS CUI-1
C0005910
Body weight
Beschrijving

Body weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Beschrijving

Temperature

Alias
UMLS CUI-1
C0005903
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Beschrijving

Route

Datatype

integer

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

Area / Village of residence

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

Geographical area

Datatype

integer

Alias
UMLS CUI [1]
C0681784
Bednet usage
Beschrijving

Bednet usage

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

Bednet use last night

Datatype

boolean

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

if applies

Datatype

boolean

Alias
UMLS CUI [1]
C2717999
Indoor residual spraying
Beschrijving

Indoor residual spraying

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

Indoor residual spraying of house

Datatype

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
Beschrijving

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?
Beschrijving

Cohort 1 only from Malaria-026

Datatype

integer

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0580670
UMLS CUI [1,3]
C0033105
UMLS CUI [1,4]
C0242723
Terug naar het begin van de pagina

Similar models

Visit 2: Demographics, Examination, Malaria control

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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