ID

24987

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2017-08-23 2017-08-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 augusti 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

GSK non-inferiority of Tritanrix Hepatitis B VISIT 5 NCT00290303

Engelsk

GSK non-inferiority of Tritanrix Hepatitis B VISIT 5 NCT00290303

1 Formulär  
REMINDERS
Beskrivning

REMINDERS

Alias
UMLS CUI-1
C1709896
ELIMINATION CRITERIA
Beskrivning

ELIMINATION CRITERIA

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

elimination criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
ADVERSE EVENTS
Beskrivning

ADVERSE EVENTS

Alias
UMLS CUI-1
C0877248
MEDICATION
Beskrivning

MEDICATION

Alias
UMLS CUI-1
C0013227
CHECK FOR STUDY CONTINUATION
Beskrivning

CHECK FOR STUDY CONTINUATION

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

Did the subject return for visit 5 ?

Datatyp

boolean

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

no return

Datatyp

integer

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

no return other

Datatyp

text

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

Decision

Datatyp

integer

Alias
UMLS CUI [1]
C0679006
LABORATORY TESTS
Beskrivning

LABORATORY TESTS

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

blood sample

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
blood sample date
Beskrivning

blood sample date

Datatyp

date

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

INCENTIVE CONCOMITANT VACCINATION

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

Flu incentive vaccine

Datatyp

boolean

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

Flu incentive vaccine date

Datatyp

date

Alias
UMLS CUI [1,1]
C0042200
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0011008
Tillbaka till toppen

Similar models

GSK non-inferiority of Tritanrix Hepatitis B VISIT 5 NCT00290303

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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