ID

25136

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 study conclusion form

Keywords

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

GlaxoSmithKline

Uploaded on

August 27, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B study conclusion NCT00290303

English

GSK non-inferiority of Tritanrix Hepatitis B study conclusion NCT00290303

1 forms  
STUDY CONCLUSION FOR MENCEVAX™ ACWY 1/5th OF A DOSE STAGE
Description

STUDY CONCLUSION FOR MENCEVAX™ ACWY 1/5th OF A DOSE STAGE

Alias
UMLS CUI-1
C1707478
Did the subject experience any Serious Adverse Event during the study period ?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Specify total number of SAE´s:
Description

number of SAE

Data type

text

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Did any elimination criteria become applicable during the study? If Yes, please specify
Description

elimination criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
Did any elimination criteria become applicable during the study? If Yes, please specify
Description

elimination criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
Was the subject withdrawn from study?
Description

withdrawn

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
Major reason for withdrawal
Description

Major reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
Who made the decision:
Description

Decision:

Data type

integer

Alias
UMLS CUI [1]
C0679006
Date of last contact
Description

Date of last contact

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Was the subject in good condition at date of last contact
Description

Was the subject in good condition at date of last contact

Data type

integer

Alias
UMLS CUI [1]
C0348080
Investigators signature
Description

Investigators signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Printed Investigators name
Description

Printed Investigators 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 study conclusion NCT00290303

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
STUDY CONCLUSION FOR MENCEVAX™ ACWY 1/5th OF A DOSE STAGE
C1707478 (UMLS CUI-1)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
number of SAE
Item
Specify total number of SAE´s:
text
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
elimination criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
boolean
C0680251 (UMLS CUI [1])
elimination criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
text
C0680251 (UMLS CUI [1])
withdrawn
Item
Was the subject withdrawn from study?
boolean
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Major reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Major reason for withdrawal
Code List
Major reason for withdrawal
CL Item
Non Serious adverse event (AEX)
CL Item
Consent withdrawal not due to an adverse event (CWS)
CL Item
Lost to follow up (LFU)
CL Item
Migrated moved from the study area (MIG)
CL Item
Other (OTH)
CL Item
Protocol violation (PTV)
CL Item
Serious adverse event (SAE)
Item
Who made the decision:
integer
C0679006 (UMLS CUI [1])
Decision:
Code List
Who made the decision:
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item
Was the subject in good condition at date of last contact
integer
C0348080 (UMLS CUI [1])
Was the subject in good condition at date of last contact
Code List
Was the subject in good condition at date of last contact
CL Item
No, Please give details in Adverse Events section. (1)
CL Item
Yes (2)
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Printed Investigators name
Item
Printed Investigators name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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