ID

36614

Description

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Keywords

Versions (1)
  1. 5/26/19 5/26/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 26, 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 :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

English

Medication

1 forms  
  1. StudyEvent: ODM
    1. Medication
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered during study period?
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Trade / Generic Name
Description

Pharmaceutical Preparations, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Medical Indication
Description

Pharmaceutical Preparations, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Total daily dose
Description

Pharmaceutical Preparations, Daily Dose, Total

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Route
Description

Pharmaceutical Preparations, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013153
Start Date
Description

Pharmaceutical Preparations, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Description

Pharmaceutical Preparations, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Tick box if continuing at end of study
Description

Pharmaceutical Preparations, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Back to the top of the page

Similar models

Medication

1 forms
  1. StudyEvent: ODM
    1. Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Pharmaceutical Preparations
Item
Have any medications/treatments been administered during study period?
boolean
C0013227 (UMLS CUI [1])
Pharmaceutical Preparations, Medication name
Item
Trade / Generic Name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Indication
Item
Medical Indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Drug Administration Routes
Item
Route
text
C0013227 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Pharmaceutical Preparations, Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations, End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Tick box if continuing at end of study
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Back to the top of the page 

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