ID

24987

Beschrijving

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 VISIT 5 form

Trefwoorden

Versies (1)
  1. 23-08-17 23-08-17 -
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GlaxoSmithKline

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23 augustus 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B VISIT 5 NCT00290303

Engels

GSK non-inferiority of Tritanrix Hepatitis B VISIT 5 NCT00290303

1 Formulieren  
REMINDERS
Beschrijving

REMINDERS

Alias
UMLS CUI-1
C1709896
ELIMINATION CRITERIA
Beschrijving

ELIMINATION CRITERIA

Alias
UMLS CUI-1
C0680251
Please check all appropriate criteria before continuing the visit.
Beschrijving

elimination criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
ADVERSE EVENTS
Beschrijving

ADVERSE EVENTS

Alias
UMLS CUI-1
C0877248
MEDICATION
Beschrijving

MEDICATION

Alias
UMLS CUI-1
C0013227
CHECK FOR STUDY CONTINUATION
Beschrijving

CHECK FOR STUDY CONTINUATION

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 5 ?
Beschrijving

Did the subject return for visit 5 ?

Datatype

boolean

Alias
UMLS CUI [1]
C0545082
If no return because:
Beschrijving

no return

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1548100
If no return because:
Beschrijving

no return other

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1548100
UMLS CUI [1,3]
C0392360
Please tick who made the decision
Beschrijving

Decision

Datatype

integer

Alias
UMLS CUI [1]
C0679006
LABORATORY TESTS
Beschrijving

LABORATORY TESTS

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Beschrijving

blood sample

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
blood sample date
Beschrijving

blood sample date

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
INCENTIVE CONCOMITANT VACCINATION
Beschrijving

INCENTIVE CONCOMITANT VACCINATION

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has the Flu incentive vaccine been administered ?
Beschrijving

Flu incentive vaccine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042200
UMLS CUI [1,2]
C1533734
Has the Flu incentive vaccine been administered ? Date:
Beschrijving

Flu incentive vaccine date

Datatype

date

Alias
UMLS CUI [1,1]
C0042200
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0011008
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Similar models

GSK non-inferiority of Tritanrix Hepatitis B VISIT 5 NCT00290303

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
REMINDERS
C1709896 (UMLS CUI-1)
Item Group
ELIMINATION CRITERIA
C0680251 (UMLS CUI-1)
elimination criteria
Item
Please check all appropriate criteria before continuing the visit.
boolean
C0680251 (UMLS CUI [1])
Item Group
ADVERSE EVENTS
C0877248 (UMLS CUI-1)
Item Group
MEDICATION
C0013227 (UMLS CUI-1)
Item Group
CHECK FOR STUDY CONTINUATION
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Did the subject return for visit 5 ?
Item
Did the subject return for visit 5 ?
boolean
C0545082 (UMLS CUI [1])
Item
If no return because:
integer
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
no return
Code List
If no return because:
CL Item
Serious adverse event  (1)
CL Item
Non-Serious adverse event  (2)
CL Item
Other, please specify: (3)
no return other
Item
If no return because:
text
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item
Please tick who made the decision
integer
C0679006 (UMLS CUI [1])
Decision
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
LABORATORY TESTS
C0022885 (UMLS CUI-1)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
blood sample date
Item
blood sample date
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item Group
INCENTIVE CONCOMITANT VACCINATION
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Flu incentive vaccine
Item
Has the Flu incentive vaccine been administered ?
boolean
C0042200 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Flu incentive vaccine date
Item
Has the Flu incentive vaccine been administered ? Date:
date
C0042200 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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