ID

28997

Description

A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.

Keywords

  1. 2/20/18 2/20/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 20, 2018

DOI

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License

Creative Commons BY-NC 3.0

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DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518

Visit1 Informed consent and Demographics

Default Itemgroup
Description

Default Itemgroup

Alias
UMLS CUI-1
C0021430
UMLS CUI-3
C0011298
I certify that Informed Consent has been obtained prior to any study procedure.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Centre number
Description

Centre number

Data type

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
date of birth
Description

date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510

Similar models

Visit1 Informed consent and Demographics

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Default Itemgroup
C0021430 (UMLS CUI-1)
C0011298 (UMLS CUI-3)
Informed consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1])
Centre number
Item
Centre number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
date of birth
Item
date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Code List
Gender
CL Item
Male ([M])
CL Item
Female ([F])
Item
Race
integer
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
Black (1)
(Comment:en)
CL Item
Arabic/North African (2)
(Comment:en)
CL Item
White/Caucasian (3)
(Comment:en)
CL Item
East & South East Asian (4)
(Comment:en)
CL Item
South Asian (5)
(Comment:en)
CL Item
American Hispanic (6)
(Comment:en)
CL Item
Japanese (7)
(Comment:en)
CL Item
Other, please specify (8)
(Comment:en)

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