ID

32998

Beskrivning

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

Nyckelord

Versioner (2)
  1. 2018-11-23 2018-11-23 -
  2. 2018-11-23 2018-11-23 -
Rättsinnehavare

GSK group of companies

Uppladdad den

23 november 2018

DOI

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Creative Commons BY-NC 3.0
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Immogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

Engelsk

Vaccine Administration (Group Priorix+Varilrix)

1 Formulär  
Administrative data
Beskrivning

Administrative data

Visit Number
Beskrivning

Visit Number

Datatyp

text

Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Vaccine Administration
Beskrivning

Vaccine Administration

Date
Beskrivning

Date

Datatyp

date

Pre-Vaccination temperature
Beskrivning

Pre-Vaccination temperature

Datatyp

float

Måttenheter
  • °C
°C
Route
Beskrivning

Route

Datatyp

text

Vaccine
Beskrivning

Vaccine

Only one box must be ticked by vaccine
Beskrivning

Only one box must be ticked by vaccine

Datatyp

text

if Replacement vial, record number
Beskrivning

if Replacement vial, record number

Datatyp

integer

If Wrong vial number, please record the correct one
Beskrivning

If Wrong vial number, please record the correct one

Datatyp

integer

Side/ Site/ Route
Beskrivning

Side/ Site/ Route

Side of injection
Beskrivning

Side of injection

Datatyp

text

Site of injection
Beskrivning

Site of injection

Datatyp

text

Route of injection
Beskrivning

Route of injection

Datatyp

text

Administration according to Protocol
Beskrivning

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Beskrivning

Has the study vaccine been administered according to protocol?

Datatyp

boolean

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

If No, please tick all items that apply: Side

Datatyp

integer

Site
Beskrivning

Site

Datatyp

text

Route
Beskrivning

Route

Datatyp

text

Comment
Beskrivning

Comment

Datatyp

text

Vaccine 2
Beskrivning

Vaccine 2

Only one box must be ticked by vaccine 2
Beskrivning

Only one box must be ticked by vaccine 2

Datatyp

text

if Replacement vial, record number
Beskrivning

if Replacement vial, record number

Datatyp

integer

If Wrong vial number, please record the correct one
Beskrivning

If Wrong vial number, please record the correct one

Datatyp

integer

Side/ Site/ Route
Beskrivning

Side/ Site/ Route

Side of Injection
Beskrivning

Side of Injection

Datatyp

text

Site of injection
Beskrivning

Site of injection

Datatyp

text

Route of injection
Beskrivning

Route of injection

Datatyp

text

Administration according to Protocol
Beskrivning

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Beskrivning

Has the study vaccine been administered according to protocol?

Datatyp

boolean

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

If No, please tick all items that apply: Side

Datatyp

integer

Site
Beskrivning

Site

Datatyp

text

Route
Beskrivning

Route

Datatyp

text

Comment
Beskrivning

Comment

Datatyp

text

Non administration
Beskrivning

Non administration

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

Please tick the ONE most appropriate category for non-administration

Datatyp

text

If SAE, record the event number
Beskrivning

If SAE, record the event number

Datatyp

integer

If Non-SAE, record the event number
Beskrivning

If Non-SAE, record the event number

Datatyp

integer

If Other, please specify
Beskrivning

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

Datatyp

text

Please tick who took the decision
Beskrivning

Please tick who took the decision

Datatyp

text

Immediate Post-Vaccination Observation
Beskrivning

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.
Beskrivning

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

Datatyp

text

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

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

Datatyp

text

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Similar models

Vaccine Administration (Group Priorix+Varilrix)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 1 (1)
Date of Visit
Item
Date of Visit
date
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
Priorix 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
Site of injection
Code List
Side of injection
CL Item
Left Upper arm (1)
Item
Site of injection
text
Site of injection
Code List
Site of injection
CL Item
Deltoid region  (1)
Item
Route of injection
text
Route of injection
Code List
Route of injection
CL Item
S.C. (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
Varilrix 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 Upper arm (1)
Item
Site of injection
text
Site of injection
Code List
Site of injection
CL Item
Deltoid region  (1)
Item
Route of injection
text
Route of injection
Code List
Route of injection
CL Item
S.C. (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)
If SAE, record the event number
Item
If SAE, record the event number
integer
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
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