ID

33067

Description

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

Versions (2)
  1. 11/23/18 11/23/18 -
  2. 11/26/18 11/26/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 26, 2018

DOI

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License

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

English

Visit 2: Vaccine Administration

1 forms  
Administrative data
Description

Administrative data

Visit Number
Description

Visit Number

Data type

text

Date of Visit
Description

Date of Visit

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Vaccine Administration
Description

Vaccine Administration

Date
Description

Date

Data type

date

Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
°C
Route
Description

Route

Data type

text

Vaccine
Description

Vaccine

Only ONE box must be ticked by vaccine
Description

Only ONE box must be ticked by vaccine

Data type

text

if Replacement vial, record number
Description

if Replacement vial, record number

Data type

integer

If Wrong vial number, please record the correct one
Description

If Wrong vial number, please record the correct one

Data type

integer

Side/ Site/ Route
Description

Side/ Site/ Route

Side of injection
Description

Side of injection

Data type

text

Site of injection
Description

Site of injection

Data type

text

Route of injection
Description

Route of injection

Data type

text

Administration according to Protocol
Description

Administration according to Protocol

Has the study vaccine been administered according to protocol?
Description

If any adverse event soccurred during the immediate post-vaccination time (30 min) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a SAE form. If any prophylactic medication has been administered -> Medication Form; If any other vaccines administered -> Concomitant Vaccination form.

Data type

boolean

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

If No, please tick all items that apply: Side

Data type

integer

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Comment
Description

Comment

Data type

text

Non-administration
Description

Non-administration

Please tick ONE most appropriate category for non administration
Description

Please tick ONE most appropriate category for non administration

Data type

text

If SAE, specify SAE Number
Description

If SAE, specify SAE Number

Data type

integer

If Non-SAE, please specify unsolicited AE Number
Description

If Non-SAE, please specify unsolicited AE Number

Data type

integer

If Other, please specify
Description

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

Data type

text

Please tick who took the decision
Description

Please tick who took the decision

Data type

text

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Similar models

Visit 2: Vaccine Administration

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
Visit 2 (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
MeMuRu-OKA 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
Non-administration
Item
Please tick ONE most appropriate category for non administration
text
Please tick ONE most appropriate category for non administration
Code List
Please tick ONE most appropriate category for non administration
CL Item
Serious Adverse Event (complete the SAE form)  (1)
CL Item
Non-Serious adverse event (complete the Non-SAE form) (2)
CL Item
Other (3)
If SAE, specify SAE Number
Item
If SAE, specify SAE Number
integer
If Non-SAE, please specify unsolicited AE Number
Item
If Non-SAE, please specify unsolicited AE 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)
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