ID

30019

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: Visit 4, Month 5, 30-48 days after Visit 3

Keywords

Versions (2)
  1. 7/11/17 7/11/17 -
  2. 5/4/18 5/4/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 4, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix Visit 4 100791

English

Visit 4 Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix 100791

1 forms  
Check for Study Continuation
Description

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject come at visit 4 ?
Description

subject return for visit

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
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]
C0392360
UMLS CUI [1,2]
C0457454
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
Other reason for Study Discontinuation
Description

If Other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
reason for study discontinuation
Description

reason for study discontinuation

Data type

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Return of diary cards
Description

Return of diary cards

Data type

boolean

Alias
UMLS CUI [1,1]
C0018700
UMLS CUI [1,2]
C0332156
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Similar models

Visit 4 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
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject come at visit 4 ?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject return for visit 2
Code List
Did the subject come at visit 4 ?
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please specify (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (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
Other (3)
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])
Other reason for Study Discontinuation
Item
Other reason for Study Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for study discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
non administration
Code List
reason for study discontinuation
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Return of diary cards
Item
Return of diary cards
boolean
C0018700 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
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