ID

24865

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 INTER-VISIT CONTACT 2 form

Keywords

Versions (1)
  1. 8/20/17 8/20/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 20, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B INTER-VISIT CONTACT 2 NCT00290303

English

ODM-Form

1 forms  
  1. StudyEvent: ODM
    1. ODM-Form
General
Description

General

Alias
UMLS CUI-1
C0205246
Date of Visit
Description

Date of Visit

Data type

integer

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
PREVIOUS STUDY
Description

PREVIOUS STUDY

Data type

text

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

DEMOGRAPHICS

Alias
UMLS CUI-1
C1704791
Center number
Description

Center number

Data type

integer

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

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

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

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

Data type

boolean

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

Serious Adverse Events

Data type

integer

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

Serious Adverse Events

Data type

boolean

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

RANDOMISATION / TREATMENT ALLOCATION

Alias
UMLS CUI-1
C0034656
Record treatment number
Description

Record treatment number

Data type

text

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
INCENTIVE CONCOMITANT VACCINATION
Description

INCENTIVE CONCOMITANT VACCINATION

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

Flu incentive vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0042200
UMLS CUI [1,2]
C1533734
flu vaccination date
Description

flu vaccination date

Data type

date

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

ODM-Form

1 forms
  1. StudyEvent: ODM
    1. ODM-Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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