ID

36774

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 form is to be completed at Visit 3.

Link

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

Keywords

  1. 12/12/18 12/12/18 -
  2. 6/6/19 6/6/19 -
Copyright Holder

GSK group of companies

Uploaded on

June 6, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

Visit 3: Physical Examination

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

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Body Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Description

Route

Data type

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974

Similar models

Visit 3: Physical Examination

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
Physical Examination
C0031809 (UMLS CUI-1)
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
integer
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
Route
CL Item
oral (1)
CL Item
axillary (2)
CL Item
rectal (3)

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