ID

36770

Beskrivning

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/NCT00323622 This form is to be completed at Visit 3.

Länk

https://clinicaltrials.gov/ct2/show/NCT00323622

Nyckelord

  1. 2018-12-12 2018-12-12 -
  2. 2019-06-06 2019-06-06 -
Rättsinnehavare

GSK group of companies

Uppladdad den

6 juni 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

Visit 3: Bednet use and Malaria control

Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beskrivning

Visit 3, Study month 45 (45 months post dose 1 in Malaria-026; 12 Months after visit 2) New item

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Bednet usage
Beskrivning

Bednet usage

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

bednet usage last night

Datatyp

boolean

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

if applies

Datatyp

boolean

Alias
UMLS CUI [1]
C2717999
Indoor residual spraying
Beskrivning

Indoor residual spraying

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

Indoor residual spraying of house?

Datatyp

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
Beskrivning

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?
Beskrivning

Cohort 1 only from Malaria-026

Datatyp

integer

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

Similar models

Visit 3: Bednet use and Malaria control

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Bednet usage
C2717998 (UMLS CUI-1)
bednet usage 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])
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)

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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