ID

24865

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 INTER-VISIT CONTACT 2 form

Nyckelord

Versioner (1)
  1. 2017-08-20 2017-08-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 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 INTER-VISIT CONTACT 2 NCT00290303

Engelsk

ODM-Form

1 Formulär  
  1. StudyEvent: ODM
    1. ODM-Form
General
Beskrivning

General

Alias
UMLS CUI-1
C0205246
Date of Visit
Beskrivning

Date of Visit

Datatyp

integer

Alias
UMLS CUI [1]
C1320303
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
PREVIOUS STUDY
Beskrivning

PREVIOUS STUDY

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205156
DEMOGRAPHICS
Beskrivning

DEMOGRAPHICS

Alias
UMLS CUI-1
C1704791
Center number
Beskrivning

Center number

Datatyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Beskrivning

Date of Birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Has the subject had any serious adverse event between end of visit 3 and inter-visit contact 2?
Beskrivning

Has the subject had any serious adverse event between end of visit 3 and inter-visit contact 2?

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Events: Specify number of SAEs:
Beskrivning

Serious Adverse Events

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Serious Adverse Events: Check SAE forms have been submitted to GSK Biologicals
Beskrivning

Serious Adverse Events

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
RANDOMISATION / TREATMENT ALLOCATION
Beskrivning

RANDOMISATION / TREATMENT ALLOCATION

Alias
UMLS CUI-1
C0034656
Record treatment number
Beskrivning

Record treatment number

Datatyp

text

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
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
flu vaccination date
Beskrivning

flu vaccination date

Datatyp

date

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

Similar models

ODM-Form

1 Formulär
  1. StudyEvent: ODM
    1. ODM-Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General
C0205246 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
integer
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
PREVIOUS STUDY
text
C2348568 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
PREVIOUS STUDY
Code List
PREVIOUS STUDY
CL Item
HIB-MENAC-TT-020 (105239 (DTPw-HBV)
CL Item
BST:011 (24-30 M Mencev)) (BST:011 (24-30 M Mencev)))
Item Group
DEMOGRAPHICS
C1704791 (UMLS CUI-1)
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Has the subject had any serious adverse event between end of visit 3 and inter-visit contact 2?
Item
Has the subject had any serious adverse event between end of visit 3 and inter-visit contact 2?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Events
Item
Serious Adverse Events: Specify number of SAEs:
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Serious Adverse Events
Item
Serious Adverse Events: Check SAE forms have been submitted to GSK Biologicals
boolean
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
RANDOMISATION / TREATMENT ALLOCATION
C0034656 (UMLS CUI-1)
Record treatment number
Item
Record treatment number
text
C1522541 (UMLS CUI [1,1])
C0600091 (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 vaccination date
Item
flu vaccination 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