ID

32998

Descrizione

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

Keywords

versioni (2)
  1. 23/11/18 23/11/18 -
  2. 23/11/18 23/11/18 -
Titolare del copyright

GSK group of companies

Caricato su

23 novembre 2018

DOI

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Licenza

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

Inglese

Vaccine Administration (Group Priorix+Varilrix)

1 moduli  
Administrative data
Descrizione

Administrative data

Visit Number
Descrizione

Visit Number

Tipo di dati

text

Date of Visit
Descrizione

Date of Visit

Tipo di dati

date

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Vaccine Administration
Descrizione

Vaccine Administration

Date
Descrizione

Date

Tipo di dati

date

Pre-Vaccination temperature
Descrizione

Pre-Vaccination temperature

Tipo di dati

float

Unità di misura
  • °C
°C
Route
Descrizione

Route

Tipo di dati

text

Vaccine
Descrizione

Vaccine

Only one box must be ticked by vaccine
Descrizione

Only one box must be ticked by vaccine

Tipo di dati

text

if Replacement vial, record number
Descrizione

if Replacement vial, record number

Tipo di dati

integer

If Wrong vial number, please record the correct one
Descrizione

If Wrong vial number, please record the correct one

Tipo di dati

integer

Side/ Site/ Route
Descrizione

Side/ Site/ Route

Side of injection
Descrizione

Side of injection

Tipo di dati

text

Site of injection
Descrizione

Site of injection

Tipo di dati

text

Route of injection
Descrizione

Route of injection

Tipo di dati

text

Administration according to Protocol
Descrizione

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Descrizione

Has the study vaccine been administered according to protocol?

Tipo di dati

boolean

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

If No, please tick all items that apply: Side

Tipo di dati

integer

Site
Descrizione

Site

Tipo di dati

text

Route
Descrizione

Route

Tipo di dati

text

Comment
Descrizione

Comment

Tipo di dati

text

Vaccine 2
Descrizione

Vaccine 2

Only one box must be ticked by vaccine 2
Descrizione

Only one box must be ticked by vaccine 2

Tipo di dati

text

if Replacement vial, record number
Descrizione

if Replacement vial, record number

Tipo di dati

integer

If Wrong vial number, please record the correct one
Descrizione

If Wrong vial number, please record the correct one

Tipo di dati

integer

Side/ Site/ Route
Descrizione

Side/ Site/ Route

Side of Injection
Descrizione

Side of Injection

Tipo di dati

text

Site of injection
Descrizione

Site of injection

Tipo di dati

text

Route of injection
Descrizione

Route of injection

Tipo di dati

text

Administration according to Protocol
Descrizione

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Descrizione

Has the study vaccine been administered according to protocol?

Tipo di dati

boolean

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

If No, please tick all items that apply: Side

Tipo di dati

integer

Site
Descrizione

Site

Tipo di dati

text

Route
Descrizione

Route

Tipo di dati

text

Comment
Descrizione

Comment

Tipo di dati

text

Non administration
Descrizione

Non administration

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

Please tick the ONE most appropriate category for non-administration

Tipo di dati

text

If SAE, record the event number
Descrizione

If SAE, record the event number

Tipo di dati

integer

If Non-SAE, record the event number
Descrizione

If Non-SAE, record the event number

Tipo di dati

integer

If Other, please specify
Descrizione

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

Tipo di dati

text

Please tick who took the decision
Descrizione

Please tick who took the decision

Tipo di dati

text

Immediate Post-Vaccination Observation
Descrizione

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.
Descrizione

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

Tipo di dati

text

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

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

Tipo di dati

text

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Similar models

Vaccine Administration (Group Priorix+Varilrix)

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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