ID

25006

Description

Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis This form contains the Medication form

Keywords

Versions (1)
  1. 8/24/17 8/24/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 24, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B Medication NCT00290303

English

GSK non-inferiority of Tritanrix Hepatitis B Medication NCT00290303

1 forms  
MEDICATION
Description

MEDICATION

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

Have any medications/treatments been administered during study period?

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0087111
Trade / Generic Name
Description

Trade / Generic Name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0013227
Medical Indication: Prophylactic
Description

Medical Indication

Data type

boolean

Alias
UMLS CUI [1,1]
C0199176
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0013227
Medical Indication
Description

Medical Indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total Daily Dose
Description

Total Daily Dose

Data type

text

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

Route

Data type

text

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

Start date

Data type

date

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

End date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing?
Description

Continuing?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
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Similar models

GSK non-inferiority of Tritanrix Hepatitis B Medication NCT00290303

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
MEDICATION
C0013227 (UMLS CUI-1)
Item
Have any medications/treatments been administered during study period?
integer
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Have any medications/treatments been administered during study period?
Code List
Have any medications/treatments been administered during study period?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Trade / Generic Name
Item
Trade / Generic Name
text
C0027365 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Item
Medical Indication: Prophylactic
boolean
C0199176 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Medical Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Continuing?
Item
Continuing?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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