ID

36759

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 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 document is to be completed at Visit 1 (if consent is given).

Link

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

Keywords

Versions (3)
  1. 12/11/18 12/11/18 -
  2. 6/5/19 6/5/19 -
  3. 6/6/19 6/6/19 - Sarah Riepenhausen
Copyright Holder

GSK group of companies

Uploaded on

June 6, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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.

Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

English

Visit 1: Consent Form

1 forms  
  1. StudyEvent: ODM
    1. Visit 1: Consent Form
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Visit 1, Study month 21 (21 months post dose 1 in Malaria-026)

Data type

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
I certify that written/thumb-printed Informed Consent has been obtained prior to any study procedure on the date below
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Back to the top of the page

Similar models

Visit 1: Consent Form

1 forms
  1. StudyEvent: ODM
    1. Visit 1: Consent Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
I certify that written/thumb-printed Informed Consent has been obtained prior to any study procedure on the date below
date
C2985782 (UMLS CUI [1])
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