ID

32998

Beschreibung

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

Stichworte

Versionen (2)
  1. 23.11.18 23.11.18 -
  2. 23.11.18 23.11.18 -
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GSK group of companies

Hochgeladen am

23. November 2018

DOI

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Immogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

Englisch

Vaccine Administration (Group Priorix+Varilrix)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Visit Number
Beschreibung

Visit Number

Datentyp

text

Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Vaccine Administration
Beschreibung

Vaccine Administration

Date
Beschreibung

Date

Datentyp

date

Pre-Vaccination temperature
Beschreibung

Pre-Vaccination temperature

Datentyp

float

Maßeinheiten
  • °C
°C
Route
Beschreibung

Route

Datentyp

text

Vaccine
Beschreibung

Vaccine

Only one box must be ticked by vaccine
Beschreibung

Only one box must be ticked by vaccine

Datentyp

text

if Replacement vial, record number
Beschreibung

if Replacement vial, record number

Datentyp

integer

If Wrong vial number, please record the correct one
Beschreibung

If Wrong vial number, please record the correct one

Datentyp

integer

Side/ Site/ Route
Beschreibung

Side/ Site/ Route

Side of injection
Beschreibung

Side of injection

Datentyp

text

Site of injection
Beschreibung

Site of injection

Datentyp

text

Route of injection
Beschreibung

Route of injection

Datentyp

text

Administration according to Protocol
Beschreibung

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Beschreibung

Has the study vaccine been administered according to protocol?

Datentyp

boolean

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

If No, please tick all items that apply: Side

Datentyp

integer

Site
Beschreibung

Site

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

Comment
Beschreibung

Comment

Datentyp

text

Vaccine 2
Beschreibung

Vaccine 2

Only one box must be ticked by vaccine 2
Beschreibung

Only one box must be ticked by vaccine 2

Datentyp

text

if Replacement vial, record number
Beschreibung

if Replacement vial, record number

Datentyp

integer

If Wrong vial number, please record the correct one
Beschreibung

If Wrong vial number, please record the correct one

Datentyp

integer

Side/ Site/ Route
Beschreibung

Side/ Site/ Route

Side of Injection
Beschreibung

Side of Injection

Datentyp

text

Site of injection
Beschreibung

Site of injection

Datentyp

text

Route of injection
Beschreibung

Route of injection

Datentyp

text

Administration according to Protocol
Beschreibung

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Beschreibung

Has the study vaccine been administered according to protocol?

Datentyp

boolean

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

If No, please tick all items that apply: Side

Datentyp

integer

Site
Beschreibung

Site

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

Comment
Beschreibung

Comment

Datentyp

text

Non administration
Beschreibung

Non administration

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

Please tick the ONE most appropriate category for non-administration

Datentyp

text

If SAE, record the event number
Beschreibung

If SAE, record the event number

Datentyp

integer

If Non-SAE, record the event number
Beschreibung

If Non-SAE, record the event number

Datentyp

integer

If Other, please specify
Beschreibung

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

Datentyp

text

Please tick who took the decision
Beschreibung

Please tick who took the decision

Datentyp

text

Immediate Post-Vaccination Observation
Beschreibung

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.
Beschreibung

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

Datentyp

text

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

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

Datentyp

text

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Ähnliche Modelle

Vaccine Administration (Group Priorix+Varilrix)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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