ID

32998

Beschrijving

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

Trefwoorden

Versies (2)
  1. 23-11-18 23-11-18 -
  2. 23-11-18 23-11-18 -
Houder van rechten

GSK group of companies

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23 november 2018

DOI

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Licentie

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

Engels

Vaccine Administration (Group Priorix+Varilrix)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Visit Number
Beschrijving

Visit Number

Datatype

text

Date of Visit
Beschrijving

Date of Visit

Datatype

date

Subject Number
Beschrijving

Subject Number

Datatype

integer

Vaccine Administration
Beschrijving

Vaccine Administration

Date
Beschrijving

Date

Datatype

date

Pre-Vaccination temperature
Beschrijving

Pre-Vaccination temperature

Datatype

float

Maateenheden
  • °C
°C
Route
Beschrijving

Route

Datatype

text

Vaccine
Beschrijving

Vaccine

Only one box must be ticked by vaccine
Beschrijving

Only one box must be ticked by vaccine

Datatype

text

if Replacement vial, record number
Beschrijving

if Replacement vial, record number

Datatype

integer

If Wrong vial number, please record the correct one
Beschrijving

If Wrong vial number, please record the correct one

Datatype

integer

Side/ Site/ Route
Beschrijving

Side/ Site/ Route

Side of injection
Beschrijving

Side of injection

Datatype

text

Site of injection
Beschrijving

Site of injection

Datatype

text

Route of injection
Beschrijving

Route of injection

Datatype

text

Administration according to Protocol
Beschrijving

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Beschrijving

Has the study vaccine been administered according to protocol?

Datatype

boolean

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

If No, please tick all items that apply: Side

Datatype

integer

Site
Beschrijving

Site

Datatype

text

Route
Beschrijving

Route

Datatype

text

Comment
Beschrijving

Comment

Datatype

text

Vaccine 2
Beschrijving

Vaccine 2

Only one box must be ticked by vaccine 2
Beschrijving

Only one box must be ticked by vaccine 2

Datatype

text

if Replacement vial, record number
Beschrijving

if Replacement vial, record number

Datatype

integer

If Wrong vial number, please record the correct one
Beschrijving

If Wrong vial number, please record the correct one

Datatype

integer

Side/ Site/ Route
Beschrijving

Side/ Site/ Route

Side of Injection
Beschrijving

Side of Injection

Datatype

text

Site of injection
Beschrijving

Site of injection

Datatype

text

Route of injection
Beschrijving

Route of injection

Datatype

text

Administration according to Protocol
Beschrijving

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Beschrijving

Has the study vaccine been administered according to protocol?

Datatype

boolean

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

If No, please tick all items that apply: Side

Datatype

integer

Site
Beschrijving

Site

Datatype

text

Route
Beschrijving

Route

Datatype

text

Comment
Beschrijving

Comment

Datatype

text

Non administration
Beschrijving

Non administration

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

Please tick the ONE most appropriate category for non-administration

Datatype

text

If SAE, record the event number
Beschrijving

If SAE, record the event number

Datatype

integer

If Non-SAE, record the event number
Beschrijving

If Non-SAE, record the event number

Datatype

integer

If Other, please specify
Beschrijving

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

Datatype

text

Please tick who took the decision
Beschrijving

Please tick who took the decision

Datatype

text

Immediate Post-Vaccination Observation
Beschrijving

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.
Beschrijving

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

Datatype

text

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

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

Datatype

text

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Similar models

Vaccine Administration (Group Priorix+Varilrix)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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