ID

33061

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 (1)
  1. 26.11.18 26.11.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

26. November 2018

DOI

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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

Englisch

Parotid / Salivary Gland Swelling AE Form

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Parotid/Salivary Gland Swelling Events
Beschreibung

Parotid/Salivary Gland Swelling Events

Event Number
Beschreibung

Please report any parotid / salivary gland swelling events occurring during the study period

Datentyp

integer

Description
Beschreibung

Description

Datentyp

text

Further Details (For GSK)
Beschreibung

Further Details (For GSK)

Event Number
Beschreibung

Event Number

Datentyp

integer

Date started
Beschreibung

Date started

Datentyp

date

Date stopped
Beschreibung

Date stopped

Datentyp

date

Intensity
Beschreibung

Intensity

Datentyp

text

Saliva Sample
Beschreibung

Saliva Sample

Event Number
Beschreibung

Event Number

Datentyp

integer

Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
Beschreibung

Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?

Datentyp

boolean

If Yes, record date
Beschreibung

If Yes, record date

Datentyp

date

Relationship to Investigational products
Beschreibung

Relationship to Investigational products

Event Number
Beschreibung

Event Number

Datentyp

integer

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datentyp

boolean

Outcome
Beschreibung

Outcome

Event Number
Beschreibung

Event Number

Datentyp

integer

Outcome
Beschreibung

Outcome

Datentyp

text

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Ähnliche Modelle

Parotid / Salivary Gland Swelling AE Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Parotid/Salivary Gland Swelling Events
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Description
Item
Description
text
Item Group
Further Details (For GSK)
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Swelling without difficulties to move the jaw (1)
CL Item
Swelling with difficulties to move the jaw (2)
CL Item
Swelling and additional general symptoms (3)
Item Group
Saliva Sample
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
Item
Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
boolean
If Yes, record date
Item
If Yes, record date
date
Item Group
Relationship to Investigational products
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Item Group
Outcome
Item
Event Number
integer
Event Number
Code List
Event Number
CL Item
PS. 1 (1)
CL Item
PS. 2 (2)
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/Resolved with sequelae (4)
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