ID

25137

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 Tracking Document form

Keywords

Versions (1)
  1. 8/27/17 8/27/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 27, 2017

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License

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

English

GSK non-inferiority of Tritanrix Hepatitis B Tracking Document NCT00290303

1 forms  
Reason for non participation
Description

Reason for non participation

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

Previous Subject Number

Data type

integer

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

Date of Birth

Data type

date

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

Eligibility

Data type

boolean

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

Eligibility

Data type

text

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

follow-up

Data type

boolean

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

not willing to participate

Data type

integer

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

not willing to participate

Data type

text

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

Subject died on

Data type

date

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

Date of Contact

Data type

date

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

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

GSK non-inferiority of Tritanrix Hepatitis B Tracking Document NCT00290303

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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