ID

23702

Description

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially blinded, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB/Hib-MenAC vaccine as compared to Tritanrix™ HepB/Hiberix™ when administered to healthy infants at 2, 4, 6 months of age, who have received a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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 Documentation part: Study Conclusion

Keywords

Versions (2)
  1. 7/11/17 7/11/17 -
  2. 5/4/18 5/4/18 - Sarah Riepenhausen
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July 11, 2017

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Creative Commons BY-NC 3.0
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Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Study Conclusion 100791

English

Study Conclusion Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

1 forms  
Follow-up Studies
Description

Follow-up Studies

Alias
UMLS CUI-1
C0016441
UMLS CUI-2
C0042210
Would the subject be willing to participate in a follow-up study?
Description

follow-up study

Data type

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
reason for non participation
Description

If No, please specify the most appropriate reason

Data type

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
Description

reason for non participation

Data type

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0392360
Reason for non participation: Other, please specify
Description

reason for non participation

Data type

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
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
Total number of SAE's:
Description

If yes, please give the total number of SAE's:

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

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
Please tick the ONE most appropriate category for drop out
Description

If Yes, 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
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Description

treatment blind broken

Data type

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
If Yes, complete the date
Description

Was the treatment blind broken during the study?

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If Yes, tick one reason below:
Description

Was the treatment blind broken during the study?

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Reason treatment blind broken. If other, specify:
Description

reason treatment blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
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Similar models

Study Conclusion Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Follow-up Studies
C0016441 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
follow-up study
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for non participation
Code List
reason for non participation
CL Item
Adverse Events, or Serious Adverse Events : (1)
CL Item
Other (2)
reason for non participation
Item
Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
text
C0877248 (UMLS CUI [1])
C0558080 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
reason for non participation
Item
Reason for non participation: Other, please specify
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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
Total 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])
withdrawn
Item
Was the subject withdrawn from study?
boolean
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate category for drop out
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for withdrawal
Code List
Please tick the ONE most appropriate category for drop out
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 withdrawal
Code List
reason for withdrawal, Who made the decision?
CL Item
Investigator’s decision (1)
CL Item
Parents/Guardian’s decision (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])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
treatment blind broken
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
date treatment blind broken
Item
If Yes, complete the date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If Yes, tick one reason below:
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason treatment blind broken
Code List
If Yes, tick one reason below:
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
reason treatment blind broken
Item
Reason treatment blind broken. If other, specify:
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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