ID
36743
Description
An open Phase 2 study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A (SB257049) in Mozambican children aged 1 to 4 years at the time of first vaccine dose. 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)
- 12/11/18 12/11/18 -
- 6/5/19 6/5/19 -
- 6/6/19 6/6/19 - Sarah Riepenhausen
Copyright Holder
GSK group of companies
Uploaded on
June 5, 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.
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
Visit 1: Consent Form
- StudyEvent: ODM
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Similar models
Visit 1: Consent Form
- StudyEvent: ODM