ID

25137

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 Tracking Document form

Trefwoorden

Versies (1)
  1. 27-08-17 27-08-17 -
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GlaxoSmithKline

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27 augustus 2017

DOI

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

Engels

GSK non-inferiority of Tritanrix Hepatitis B Tracking Document NCT00290303

1 Formulieren  
Reason for non participation
Beschrijving

Reason for non participation

Alias
UMLS CUI-1
C0558080
UMLS CUI-2
C0679823
UMLS CUI-3
C0392360
Previous Subject Number
Beschrijving

Previous Subject Number

Datatype

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Date of Birth
Beschrijving

Date of Birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Subject not eligible? Please specify criteria that are not fulfilled
Beschrijving

Eligibility

Datatype

boolean

Alias
UMLS CUI [1]
C0013893
Subject not eligible? Please specify criteria that are not fulfilled
Beschrijving

Eligibility

Datatype

text

Alias
UMLS CUI [1]
C0013893
Subject lost to follow-up or not reached
Beschrijving

follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1321605
Subject eligible but not willing to participate due to:
Beschrijving

not willing to participate

Datatype

integer

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0392360
Subject eligible but not willing to participate due to: Please specify:
Beschrijving

not willing to participate

Datatype

text

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0392360
Subject died on
Beschrijving

Subject died on

Datatype

date

Alias
UMLS CUI [1,1]
C1148348
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Date of Contact
Beschrijving

Date of Contact

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
UMLS CUI [1,3]
C1522577
Investigator name
Beschrijving

Investigator name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

GSK non-inferiority of Tritanrix Hepatitis B Tracking Document NCT00290303

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Reason for non participation
C0558080 (UMLS CUI-1)
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
Previous Subject Number
Item
Previous Subject Number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Eligibility
Item
Subject not eligible? Please specify criteria that are not fulfilled
boolean
C0013893 (UMLS CUI [1])
Eligibility
Item
Subject not eligible? Please specify criteria that are not fulfilled
text
C0013893 (UMLS CUI [1])
follow-up
Item
Subject lost to follow-up or not reached
boolean
C1522577 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Item
Subject eligible but not willing to participate due to:
integer
C3846156 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
not willing to participate
Code List
Subject eligible but not willing to participate due to:
CL Item
adverse events or serious adverse event (1)
CL Item
other (2)
not willing to participate
Item
Subject eligible but not willing to participate due to: Please specify:
text
C3846156 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Subject died on
Item
Subject died on
date
C1148348 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Date of Contact
Item
Date of Contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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