ID

23892

Description

Study part: Vacccine Administration Booster Dose. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Keywords

Versions (1)
  1. 7/16/17 7/16/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 16, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Vacccine Administration Booster Dose Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

English

Vacccine Administration Booster Dose

1 forms  
Vaccine Administration Group Hib-MenCY or Hib-MenC
Description

Vaccine Administration Group Hib-MenCY or Hib-MenC

Alias
UMLS CUI-1
C2368628
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Please complete only if different from visit date :
Description

date vaccine administration

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Vaccine administration Hib-MenCY Vaccine
Description

Side / site route: Left Thigh I.M.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2352428
If Replacement vial, comment
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Has the study vaccine been administered according to the Protocol ?
Description

vaccine administration site route side

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Vaccine administration DTPa-HBV-IPV Vaccine
Description

Side / site route: Right Thigh I.M.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1121707
If Replacement vial, comment
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Has the study vaccine been administered according to the Protocol ?
Description

vaccine administration site route side

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Vaccine Administration Group Control
Description

Vaccine Administration Group Control

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0009932
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Please complete only if different from visit date :
Description

date vaccine administration

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Vaccine administration MenC Vaccine
Description

Side / site route: Left Thigh I.M.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1720015
If Replacement vial, comment
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Has the study vaccine been administered according to the Protocol ?
Description

vaccine administration site route side

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Vaccine administration DTPa-HBV-IPV/Hib Vaccine
Description

Side / site route: Right Thigh I.M.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1121707
If Replacement vial, comment
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Has the study vaccine been administered according to the Protocol ?
Description

vaccine administration site route side

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Why not administered ?
Description

Why not administered ?

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0205544
Why not administered ?
Description

Vaccine administration cancelled

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0205544
If SAE, Please specify SAE N° :
Description

SAE

Data type

text

Alias
UMLS CUI [1]
C1519255
If AEX, Please specify AE N° (Unsolicited) or code (Solicited) : :
Description

non serious adverse event

Data type

text

Alias
UMLS CUI [1]
C1518404
If other, please specify
Description

(e.g. : consent withdrawal, Protocol violation, …)

Data type

text

Alias
UMLS CUI [1]
C0205394
Please tick who took the decision :
Description

person Vaccine administration cancelled

Data type

text

Alias
UMLS CUI [1]
C0027361
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Similar models

Vacccine Administration Booster Dose

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vaccine Administration Group Hib-MenCY or Hib-MenC
C2368628 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
date vaccine administration
Item
Please complete only if different from visit date :
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Vaccine administration Hib-MenCY Vaccine
text
C2368628 (UMLS CUI [1,1])
C2352428 (UMLS CUI [1,2])
vaccine administration
Code List
Vaccine administration Hib-MenCY Vaccine
CL Item
Hib-MenCY Vaccine OR Hib-MenC Vaccine (Hib-MenCY Vaccine OR Hib-MenC Vaccine)
CL Item
Replacement vial (Replacement vial)
CL Item
Wrong vial number (Wrong vial number)
CL Item
Not administered (Not administered)
comment
Item
If Replacement vial, comment
text
C0947611 (UMLS CUI [1])
Item
Has the study vaccine been administered according to the Protocol ?
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
vaccine administration site route side
Code List
Has the study vaccine been administered according to the Protocol ?
CL Item
Yes (1)
CL Item
No, Side: Left, Site: Deltoid, Route: I.M (2)
CL Item
No, Side: Left, Site: Deltoid, Route: S.C (3)
CL Item
No, Side: Right, Site: Deltoid, Route: I.M (4)
CL Item
No, Side: Right, Site: Deltoid, Route: S.C (5)
CL Item
No, Side: Left, Site: Thigh, Route: I:M (6)
CL Item
No, Side: Left, Site: Thigh, Route: S.C (7)
CL Item
No, Side: Right, Site: Thigh, Route: I.M (8)
CL Item
No, Side: Right, Site: Thigh, Route: S.C (9)
CL Item
No, Side: Left, Site: Buttock, Route: I.M (10)
CL Item
No, Side: Left, Site: Buttock, Route: S.C (11)
CL Item
No, Side: Right, Site: Buttock, Route: I.M (12)
CL Item
No, Side: Right, Site: Buttock, Route: S.C (13)
Item
Vaccine administration DTPa-HBV-IPV Vaccine
text
C2368628 (UMLS CUI [1,1])
C1121707 (UMLS CUI [1,2])
vaccine administration DTPa-HBV-IPV Vaccine
Code List
Vaccine administration DTPa-HBV-IPV Vaccine
CL Item
DTPa-HBV-IPV Vaccine (DTPa-HBV-IPV Vaccine)
CL Item
Replacement vial (Replacement vial)
CL Item
Wrong vial number (Wrong vial number)
CL Item
Not administered (Not administered)
comment
Item
If Replacement vial, comment
text
C0947611 (UMLS CUI [1])
Item
Has the study vaccine been administered according to the Protocol ?
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
vaccine administration site route side
Code List
Has the study vaccine been administered according to the Protocol ?
CL Item
Yes (1)
CL Item
No, Side: Left, Site: Deltoid, Route: I.M (2)
CL Item
No, Side: Left, Site: Deltoid, Route: S.C (3)
CL Item
No, Side: Right, Site: Deltoid, Route: I.M (4)
CL Item
No, Side: Right, Site: Deltoid, Route: S.C (5)
CL Item
No, Side: Left, Site: Thigh, Route: I:M (6)
CL Item
No, Side: Left, Site: Thigh, Route: S.C (7)
CL Item
No, Side: Right, Site: Thigh, Route: I.M (8)
CL Item
No, Side: Right, Site: Thigh, Route: S.C (9)
CL Item
No, Side: Left, Site: Buttock, Route: I.M (10)
CL Item
No, Side: Left, Site: Buttock, Route: S.C (11)
CL Item
No, Side: Right, Site: Buttock, Route: I.M (12)
CL Item
No, Side: Right, Site: Buttock, Route: S.C (13)
Item Group
Vaccine Administration Group Control
C2368628 (UMLS CUI-1)
C0009932 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
date vaccine administration
Item
Please complete only if different from visit date :
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Vaccine administration MenC Vaccine
text
C2368628 (UMLS CUI [1,1])
C1720015 (UMLS CUI [1,2])
Vaccine administration Meningococcal vaccine
Code List
Vaccine administration MenC Vaccine
CL Item
MenC Vaccine (MenC Vaccine)
CL Item
Replacement vial (Replacement vial)
CL Item
Wrong vial number (Wrong vial number)
CL Item
Not administered (Not administered)
comment
Item
If Replacement vial, comment
text
C0947611 (UMLS CUI [1])
Item
Has the study vaccine been administered according to the Protocol ?
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
vaccine administration site route side
Code List
Has the study vaccine been administered according to the Protocol ?
CL Item
Yes (1)
CL Item
No, Side: Left, Site: Deltoid, Route: I.M (2)
CL Item
No, Side: Left, Site: Deltoid, Route: S.C (3)
CL Item
No, Side: Right, Site: Deltoid, Route: I.M (4)
CL Item
No, Side: Right, Site: Deltoid, Route: S.C (5)
CL Item
No, Side: Left, Site: Thigh, Route: I:M (6)
CL Item
No, Side: Left, Site: Thigh, Route: S.C (7)
CL Item
No, Side: Right, Site: Thigh, Route: I.M (8)
CL Item
No, Side: Right, Site: Thigh, Route: S.C (9)
CL Item
No, Side: Left, Site: Buttock, Route: I.M (10)
CL Item
No, Side: Left, Site: Buttock, Route: S.C (11)
CL Item
No, Side: Right, Site: Buttock, Route: I.M (12)
CL Item
No, Side: Right, Site: Buttock, Route: S.C (13)
Item
Vaccine administration DTPa-HBV-IPV/Hib Vaccine
text
C2368628 (UMLS CUI [1,1])
C1121707 (UMLS CUI [1,2])
vaccine administration DTPa-HBV-IPV/Hib Vaccine
Code List
Vaccine administration DTPa-HBV-IPV/Hib Vaccine
CL Item
DTPa-HBV-IPV/Hib Vaccine (DTPa-HBV-IPV/Hib Vaccine)
CL Item
Replacement vial (Replacement vial)
CL Item
Wrong vial number (Wrong vial number)
CL Item
Not administered (Not administered)
comment
Item
If Replacement vial, comment
text
C0947611 (UMLS CUI [1])
Item
Has the study vaccine been administered according to the Protocol ?
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
vaccine administration site route side
Code List
Has the study vaccine been administered according to the Protocol ?
CL Item
Yes (1)
CL Item
No, Side: Left, Site: Deltoid, Route: I.M (2)
CL Item
No, Side: Left, Site: Deltoid, Route: S.C (3)
CL Item
No, Side: Right, Site: Deltoid, Route: I.M (4)
CL Item
No, Side: Right, Site: Deltoid, Route: S.C (5)
CL Item
No, Side: Left, Site: Thigh, Route: I:M (6)
CL Item
No, Side: Left, Site: Thigh, Route: S.C (7)
CL Item
No, Side: Right, Site: Thigh, Route: I.M (8)
CL Item
No, Side: Right, Site: Thigh, Route: S.C (9)
CL Item
No, Side: Left, Site: Buttock, Route: I.M (10)
CL Item
No, Side: Left, Site: Buttock, Route: S.C (11)
CL Item
No, Side: Right, Site: Buttock, Route: I.M (12)
CL Item
No, Side: Right, Site: Buttock, Route: S.C (13)
Item Group
Why not administered ?
C2368628 (UMLS CUI-1)
C0205544 (UMLS CUI-2)
Item
Why not administered ?
text
C2368628 (UMLS CUI [1,1])
C0205544 (UMLS CUI [1,2])
Vaccine administration cancelled
Code List
Why not administered ?
CL Item
SAE) Serious adverse event (complete the Serious Adverse Event form (SAE) Serious adverse event (complete the Serious Adverse Event form)
CL Item
AEX) Non-Serious adverse event (complete the Non-serious Adverse Event form (AEX) Non-Serious adverse event (complete the Non-serious Adverse Event form)
CL Item
OTH) Other (OTH) Other)
SAE
Item
If SAE, Please specify SAE N° :
text
C1519255 (UMLS CUI [1])
non serious adverse event
Item
If AEX, Please specify AE N° (Unsolicited) or code (Solicited) : :
text
C1518404 (UMLS CUI [1])
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
Item
Please tick who took the decision :
text
C0027361 (UMLS CUI [1])
person Vaccine administration cancelled
Code List
Please tick who took the decision :
CL Item
Investigator (Investigator)
C2826892 (UMLS CUI-1)
(Comment:en)
CL Item
Parents/Guardians (Parents/Guardians)
C0030551 (UMLS CUI-1)
(Comment:en)
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