ID

36761

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 includes the reference ranges of the laboratory tests and is hence not related to a particular subject's visit.

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 -
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

English

Laboratory Reference Ranges

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Centre
Description

Centre

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Laboratory Name
Description

Laboratory Name

Alias
UMLS CUI-1
C3258037
Lab code
Description

for internal use only

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0805701
Laboratory name
Description

Laboratory name

Data type

text

Alias
UMLS CUI [1]
C3258037
Laboratory Tests Reference Ranges
Description

Laboratory Tests Reference Ranges

Alias
UMLS CUI-1
C0883335
Lower limit of age range
Description

prefilled with "4"

Data type

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1514721
UMLS CUI [1,3]
C0439081
Upper limit of age range
Description

prefilled with "110"

Data type

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1514721
UMLS CUI [1,3]
C0439085
Age units
Description

Preselected: 1 = "years"

Data type

integer

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1519795
Sex
Description

Preselected: "B" = "Male and female reference range"

Data type

text

Alias
UMLS CUI [1]
C0079399
Date these reference ranges became effective:
Description

prefilled with "01-MAR-2015"

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0883335
PCV (Packed cell volume) Hematocrit: Unit
Description

PCV (Packed cell volume) / Hematocrit belongs to "Haematology"

Data type

text

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C1519795
Low reference value
Description

Hematocrit: Lower limit of reference range

Data type

float

Alias
UMLS CUI [1,1]
C1272773
UMLS CUI [1,2]
C0518014
High reference value
Description

Hematocrit: Upper limit of reference range

Data type

float

Alias
UMLS CUI [1,1]
C1299400
UMLS CUI [1,2]
C0518014
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Similar models

Laboratory Reference Ranges

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Centre
Item
Centre
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Laboratory Name
C3258037 (UMLS CUI-1)
Lab code
Item
Lab code
text
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Laboratory name
Item
Laboratory name
text
C3258037 (UMLS CUI [1])
Item Group
Laboratory Tests Reference Ranges
C0883335 (UMLS CUI-1)
Lower limit of age range
Item
Lower limit of age range
integer
C0001779 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C0439081 (UMLS CUI [1,3])
Upper limit of age range
Item
Upper limit of age range
integer
C0001779 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
C0439085 (UMLS CUI [1,3])
Item
Age units
integer
C0001779 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Age units
Code List
Age units
CL Item
years (1)
CL Item
months (2)
CL Item
weeks (3)
CL Item
days (4)
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male reference range (M)
CL Item
Female reference range (F)
CL Item
Male and female reference range (B)
Start date of these reference ranges
Item
Date these reference ranges became effective:
date
C0808070 (UMLS CUI [1,1])
C0883335 (UMLS CUI [1,2])
Hematocrit: Unit
Item
PCV (Packed cell volume) Hematocrit: Unit
text
C0518014 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Hematocrit: Lower limit of reference range
Item
Low reference value
float
C1272773 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
Hematocrit: Upper limit of reference range
Item
High reference value
float
C1299400 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
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