ID

42539

Description

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 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 ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum 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 vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: 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). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. This form should be filled in if any unsolicited non-serious adverse events occurs during the trial period within 30 days post-vaccination. Please report all serious adverse events only on the Serious Adverse Event (SAE) report. Note that informed consent has to be obtained prior to any study procedure.

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Keywords

Versions (1)
  1. 8/24/21 8/24/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

English

Non-Serious Adverse Events

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Description

If yes, please complete the following item group for each non-serious adverse event.

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0042196
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0877248
UMLS CUI [2,3]
C1517001
Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
AE Number
Description

Non-serious adverse events number

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0600091
Description
Description

Non-serious adverse event description

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Location
Description

Non-serious adverse event anatomic site

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1515974
For GSK
Description

Clinical study sponsor comment

Data type

text

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C0947611
Date started
Description

Non-serious adverse event start date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
During immediate post-vaccination period (60 minutes)?
Description

Non-serious adverse event start date immediately post vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0205253
Date stopped
Description

Non-serious adverse event end date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Maximum intensity
Description

Non-serious adverse event maximum symptom intensity

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0806909
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Non-serious adverse event relationship to investigational products

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Outcome
Description

Non-serious adverse event outcome

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Back to the top of the page

Similar models

Non-Serious Adverse Events

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious adverse event post vaccination | excluding solicited adverse events
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332300 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Non-serious adverse events number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Non-serious adverse event description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Location
text
C1518404 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Non-serious adverse event location
Code List
Location
CL Item
Administration sites ([L])
(Comment:en)
CL Item
Non-administration site ([G])
(Comment:en)
Clinical study sponsor comment
Item
For GSK
text
C2347796 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Non-serious adverse event start date
Item
Date started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-serious adverse event start date immediately post vaccination
Item
During immediate post-vaccination period (60 minutes)?
boolean
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
Non-serious adverse event end date
Item
Date stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious adverse event maximum symptom intensity
Code List
Maximum intensity
CL Item
Mild ([1])
CL Item
Moderate ([2])
CL Item
Severe ([3])
Non-serious adverse event relationship to investigational products
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious adverse event outcome
Code List
Outcome
CL Item
Recovered / resolved ([1])
(Comment:en)
CL Item
Recovering / resolving ([2])
(Comment:en)
CL Item
Not recovered / not resolved ([3])
(Comment:en)
CL Item
Recovered with sequelae / resolved with sequelae ([4])
(Comment:en)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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