ID

23229

Description

Study ID: 104730 Clinical Study ID: 104730 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A 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 Visit 2: Study Conclusion

Link

https://clinicaltrials.gov/ct2/show/NCT00317161

Keywords

Versions (1)
  1. 6/29/17 6/29/17 -
Uploaded on

June 29, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Study Conclusion NCT00317161

English

Study Conclusion Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

1 forms  
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject experience any Serious Adverse Event during the study period ?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Number of SAE's
Description

Serious Adverse Event? If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Did any elimination criteria become applicable during the study?
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Was the subject withdrawn from study?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withdrawn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

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Description

If No, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
SAE Number
Description

If Serious adverse event, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number or Code
Description

If Non-serious adverse event, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If Protocol violation, please specify
Description

Protocol violation

Data type

text

Alias
UMLS CUI [1]
C1709750
Other reason for withdrawal
Description

If Other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
reason for withdrawal, Who made the decision?
Description

reason for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
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

subject condition

Data type

integer

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigators signature
Description

Investigators signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigators signature Date
Description

Investigators signature Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
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Similar models

Study Conclusion Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
Number of SAEs
Item
Number of SAE's
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
elimination criteria
Item
Did any elimination criteria become applicable during the study?
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])
Item
Was the subject withdrawn from study?
integer
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
subject come at visit 2
Code List
Was the subject withdrawn from study?
CL Item
No (1)
CL Item
Yes, Please tick the ONE most appropriate category for drop out. (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event. (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Protocol violation
Item
If Protocol violation, please specify
text
C1709750 (UMLS CUI [1])
Other reason for withdrawal
Item
Other reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for withdrawal, Who made the decision?
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
reason for withdrawal, Who made the decision?
CL Item
Investigator’s decision (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
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
subject condition
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section (1)
CL Item
Yes (2)
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Investigators signature Date
Item
Investigators signature Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
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