ID

33175

Description

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Keywords

Versions (1)
  1. 11/30/18 11/30/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 30, 2018

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License

Creative Commons BY-NC 3.0
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Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

English

Visit 3: Vaccine Administration (Dose 3)

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Vaccine Administration
Description

Vaccine Administration

Date
Description

Date

Data type

date

Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
°C
Route
Description

Route

Data type

text

Vaccine
Description

Vaccine

Only one box must be ticked by vaccine
Description

Only one box must be ticked by vaccine

Data type

text

if Replacement vial, record number
Description

if Replacement vial, record number

Data type

integer

If Wrong vial number, please record the correct one
Description

If Wrong vial number, please record the correct one

Data type

integer

Side/ Site/ Route
Description

Side/ Site/ Route

Side of Injection
Description

Side of Injection

Data type

text

Site of Injection
Description

Site of Injection

Data type

text

Route of injection
Description

Route of injection

Data type

text

Administration according to Protocol
Description

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Description

Has the study vaccine been administered according to protocol?

Data type

boolean

If No, please tick all items that apply: Side
Description

If No, please tick all items that apply: Side

Data type

integer

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Comment
Description

Comment

Data type

text

Vaccine 2
Description

Vaccine 2

Only one box must be ticked by vaccine 2
Description

Only one box must be ticked by vaccine 2

Data type

text

if Replacement vial, record number
Description

if Replacement vial, record number

Data type

integer

If Wrong vial number, please record the correct one
Description

If Wrong vial number, please record the correct one

Data type

integer

Side/ Site/ Route
Description

Side/ Site/ Route

Route of Injection
Description

Route of Injection

Data type

text

Administration according to Protocol
Description

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Description

Has the study vaccine been administered according to protocol?

Data type

boolean

If No, please tick all items that apply: Side
Description

If No, please tick all items that apply: Side

Data type

integer

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Comment
Description

Comment

Data type

text

Non administration
Description

Non administration

Please tick the ONE most appropriate category for non-administration
Description

Please tick the ONE most appropriate category for non-administration

Data type

text

Only one box must be ticked by vaccine 2
Description

Only one box must be ticked by vaccine 2

Data type

text

If Non-SAE, record the event number
Description

If Non-SAE, record the event number

Data type

integer

If Other, please specify
Description

e.g., consent withdrawal, protocol violation, etc

Data type

text

Please tick who took the decision
Description

Please tick who took the decision

Data type

text

Immediate Post-Vaccination Observation
Description

Immediate Post-Vaccination Observation

If any adverse events occurred during the immediate post-vaccination time (30 min), fill in the SAE or Non-SAE form.
Description

If any adverse events occurred during the immediate post-vaccination time (30 min), fill in the SAE or Non-SAE form.

Data type

text

If any prophylactic medications has been administered, please complete the Medication Form and tick prophylactic box.
Description

Any other vaccines administered must be recorded in the Concomitant Vaccination form

Data type

text

Vaccine 3
Description

Vaccine 3

Only one box must be ticked by vaccine 3
Description

Only one box must be ticked by vaccine 3

Data type

text

if Replacement vial, record number
Description

if Replacement vial, record number

Data type

integer

If Wrong vial number, please record the correct one
Description

If Wrong vial number, please record the correct one

Data type

integer

Side/ Site/ Route
Description

Side/ Site/ Route

Side of Injection
Description

Side of Injection

Data type

text

Site of Injection
Description

Site of Injection

Data type

text

Route
Description

Route

Data type

text

Administration according to Protocol
Description

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Description

Has the study vaccine been administered according to protocol?

Data type

boolean

If No, please tick all items that apply: Side
Description

If No, please tick all items that apply: Side

Data type

integer

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Comment
Description

Comment

Data type

text

Vaccine 4
Description

Vaccine 4

Only one box must be ticked by vaccine 4
Description

Only one box must be ticked by vaccine 4

Data type

text

if Replacement vial, record number
Description

if Replacement vial, record number

Data type

integer

If Wrong vial number, please record the correct one
Description

If Wrong vial number, please record the correct one

Data type

integer

Side/Site/Route
Description

Side/Site/Route

Side of Injection
Description

Side of Injection

Data type

text

Site of Injection
Description

Site of Injection

Data type

text

Route
Description

Route

Data type

text

Administration according to Protocol
Description

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Description

Has the study vaccine been administered according to protocol?

Data type

boolean

If No, please tick all items that apply: Side
Description

If No, please tick all items that apply: Side

Data type

integer

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Comment
Description

Comment

Data type

text

Commentary
Description

Commentary

Record here any necessary comments
Description

Record here any necessary comments

Data type

text

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Similar models

Visit 3: Vaccine Administration (Dose 3)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Vaccine Administration
Date
Item
Date
date
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
Item
Route
text
Route
Code List
Route
CL Item
Axillary (1)
CL Item
Rectal (2)
Item Group
Vaccine
Item
Only one box must be ticked by vaccine
text
Only one box must be ticked by vaccine
Code List
Only one box must be ticked by vaccine
CL Item
TritanrixTM-HepB Vaccine (1)
CL Item
ZilbrixTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered (5)
if Replacement vial, record number
Item
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
Item
If Wrong vial number, please record the correct one
integer
Item Group
Side/ Site/ Route
Item
Side of Injection
text
Side of Injection
Code List
Side of Injection
CL Item
Right Thigh (1)
Item
Site of Injection
text
Site of Injection
Code List
Site of Injection
CL Item
Anterolateral (1)
Item
Route of injection
text
Route of injection
Code List
Route of injection
CL Item
I.M. (1)
Item Group
Administration according to Protocol
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
Item
If No, please tick all items that apply: Side
integer
If No, please tick all items that apply: Side
Code List
If No, please tick all items that apply: Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
Site
text
Site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
Item Group
Vaccine 2
Only one box must be ticked by vaccine 2
Code List
Only one box must be ticked by vaccine 2
CL Item
RotarixTM Vaccine or Placebo (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
if Replacement vial, record number
Item
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
Item
If Wrong vial number, please record the correct one
integer
Item Group
Side/ Site/ Route
Item
Route of Injection
text
Route of Injection
Code List
Route of Injection
CL Item
Oral (1)
Item Group
Administration according to Protocol
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
Item
If No, please tick all items that apply: Side
integer
If No, please tick all items that apply: Side
Code List
If No, please tick all items that apply: Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
Site
text
Site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
Item Group
Non administration
Item
Please tick the ONE most appropriate category for non-administration
text
Please tick the ONE most appropriate category for non-administration
Code List
Please tick the ONE most appropriate category for non-administration
CL Item
[SAE] Serious adverse event (complete the SAE form) (1)
CL Item
[AEX] Non-Serious adverse event (complete the Non-serious AE section) (2)
CL Item
[OTH] Other (3)
Only one box must be ticked by vaccine 2
Code List
Only one box must be ticked by vaccine 2
CL Item
RotarixTM Vaccine or Placebo (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
If Non-SAE, record the event number
Item
If Non-SAE, record the event number
integer
If Other, please specify
Item
If Other, please specify
text
Item
Please tick who took the decision
text
Please tick who took the decision
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
Immediate Post-Vaccination Observation
If any adverse events occurred during the immediate post-vaccination time (30 min), fill in the SAE or Non-SAE form.
Item
If any adverse events occurred during the immediate post-vaccination time (30 min), fill in the SAE or Non-SAE form.
text
If any prophylactic medications has been administered, please complete the Medication Form and tick prophylactic box.
Item
If any prophylactic medications has been administered, please complete the Medication Form and tick prophylactic box.
text
Item Group
Vaccine 3
Item
Only one box must be ticked by vaccine 3
text
Only one box must be ticked by vaccine 3
Code List
Only one box must be ticked by vaccine 3
CL Item
Triple AntigenTM Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
if Replacement vial, record number
Item
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
Item
If Wrong vial number, please record the correct one
integer
Item Group
Side/ Site/ Route
Item
Side of Injection
text
Side of Injection
Code List
Side of Injection
CL Item
Left Thigh (1)
Item
Site of Injection
text
Site of Injection
Code List
Site of Injection
CL Item
Anterolateral (1)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
Item Group
Administration according to Protocol
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
Item
If No, please tick all items that apply: Side
integer
If No, please tick all items that apply: Side
Code List
If No, please tick all items that apply: Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
Site
text
Site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
Item Group
Vaccine 4
Item
Only one box must be ticked by vaccine 4
text
Only one box must be ticked by vaccine 4
Code List
Only one box must be ticked by vaccine 4
CL Item
EngerixTM-B Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
if Replacement vial, record number
Item
if Replacement vial, record number
integer
If Wrong vial number, please record the correct one
Item
If Wrong vial number, please record the correct one
integer
Item Group
Side/Site/Route
Item
Side of Injection
text
Side of Injection
Code List
Side of Injection
CL Item
Right Thigh (1)
Item
Site of Injection
text
Site of Injection
Code List
Site of Injection
CL Item
Anterolateral (1)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
Item Group
Administration according to Protocol
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
Item
If No, please tick all items that apply: Side
integer
If No, please tick all items that apply: Side
Code List
If No, please tick all items that apply: Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
Site
text
Site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comment
Item
Comment
text
Item Group
Commentary
Record here any necessary comments
Item
Record here any necessary comments
text
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