ID

32998

Descripción

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

Palabras clave

Versiones (2)
  1. 23/11/18 23/11/18 -
  2. 23/11/18 23/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

23 de noviembre de 2018

DOI

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Licencia

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

Inglés

Vaccine Administration (Group Priorix+Varilrix)

1 formularios  
Administrative data
Descripción

Administrative data

Visit Number
Descripción

Visit Number

Tipo de datos

text

Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Vaccine Administration
Descripción

Vaccine Administration

Date
Descripción

Date

Tipo de datos

date

Pre-Vaccination temperature
Descripción

Pre-Vaccination temperature

Tipo de datos

float

Unidades de medida
  • °C
°C
Route
Descripción

Route

Tipo de datos

text

Vaccine
Descripción

Vaccine

Only one box must be ticked by vaccine
Descripción

Only one box must be ticked by vaccine

Tipo de datos

text

if Replacement vial, record number
Descripción

if Replacement vial, record number

Tipo de datos

integer

If Wrong vial number, please record the correct one
Descripción

If Wrong vial number, please record the correct one

Tipo de datos

integer

Side/ Site/ Route
Descripción

Side/ Site/ Route

Side of injection
Descripción

Side of injection

Tipo de datos

text

Site of injection
Descripción

Site of injection

Tipo de datos

text

Route of injection
Descripción

Route of injection

Tipo de datos

text

Administration according to Protocol
Descripción

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Descripción

Has the study vaccine been administered according to protocol?

Tipo de datos

boolean

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

If No, please tick all items that apply: Side

Tipo de datos

integer

Site
Descripción

Site

Tipo de datos

text

Route
Descripción

Route

Tipo de datos

text

Comment
Descripción

Comment

Tipo de datos

text

Vaccine 2
Descripción

Vaccine 2

Only one box must be ticked by vaccine 2
Descripción

Only one box must be ticked by vaccine 2

Tipo de datos

text

if Replacement vial, record number
Descripción

if Replacement vial, record number

Tipo de datos

integer

If Wrong vial number, please record the correct one
Descripción

If Wrong vial number, please record the correct one

Tipo de datos

integer

Side/ Site/ Route
Descripción

Side/ Site/ Route

Side of Injection
Descripción

Side of Injection

Tipo de datos

text

Site of injection
Descripción

Site of injection

Tipo de datos

text

Route of injection
Descripción

Route of injection

Tipo de datos

text

Administration according to Protocol
Descripción

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Descripción

Has the study vaccine been administered according to protocol?

Tipo de datos

boolean

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

If No, please tick all items that apply: Side

Tipo de datos

integer

Site
Descripción

Site

Tipo de datos

text

Route
Descripción

Route

Tipo de datos

text

Comment
Descripción

Comment

Tipo de datos

text

Non administration
Descripción

Non administration

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

Please tick the ONE most appropriate category for non-administration

Tipo de datos

text

If SAE, record the event number
Descripción

If SAE, record the event number

Tipo de datos

integer

If Non-SAE, record the event number
Descripción

If Non-SAE, record the event number

Tipo de datos

integer

If Other, please specify
Descripción

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

Tipo de datos

text

Please tick who took the decision
Descripción

Please tick who took the decision

Tipo de datos

text

Immediate Post-Vaccination Observation
Descripción

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.
Descripción

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

Tipo de datos

text

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

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

Tipo de datos

text

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Similar models

Vaccine Administration (Group Priorix+Varilrix)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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