ID

33063

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. 26/11/18 26/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

26 de noviembre de 2018

DOI

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Licencia

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

Inglés

Visit 1: Solicited Adverse Events - General Symptoms (All Groups)

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

General Symptoms
Descripción

General Symptoms

Has the subject experienced any of the following signs/symptoms during the solicited period?
Descripción

Has the subject experienced any of the following signs/symptoms during the solicited period?

Tipo de datos

text

General Symptom 1
Descripción

General Symptom 1

Fever
Descripción

Fever

Tipo de datos

boolean

In any case, please complete the Temperature form
Descripción

In any case, please complete the Temperature form

Tipo de datos

text

Symptom 2
Descripción

Symptom 2

General rash/exanthema
Descripción

General rash/exanthema

Tipo de datos

boolean

If YES, please complete the Rash/Exanthema form
Descripción

If YES, please complete the Rash/Exanthema form

Tipo de datos

text

Symptom 3
Descripción

Symptom 3

Parotid/Salivary gland swelling
Descripción

Parotid/Salivary gland swelling

Tipo de datos

boolean

If YES, please complete the Parotid/Salivary Gland Swelling form
Descripción

If YES, please complete the Parotid/Salivary Gland Swelling form

Tipo de datos

text

Symptom 4
Descripción

Symptom 4

Febrile convulsions - suspected signs of meningitis
Descripción

Febrile convulsions - suspected signs of meningitis

Tipo de datos

boolean

If Yes, please complete the Febrile Convulsions - Suspected Signs of Meningitis form
Descripción

If Yes, please complete the Febrile Convulsions - Suspected Signs of Meningitis form

Tipo de datos

text

Please report serious adverse events to GSK by telephone within 24 hours
Descripción

Please report serious adverse events to GSK by telephone within 24 hours

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Similar models

Visit 1: Solicited Adverse Events - General Symptoms (All Groups)

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
General Symptoms
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Has the subject experienced any of the following signs/symptoms during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick YES for each symptom. If Yes is ticked, please complete all items. (4)
Item Group
General Symptom 1
Fever
Item
Fever
boolean
In any case, please complete the Temperature form
Item
In any case, please complete the Temperature form
text
Item Group
Symptom 2
General rash/exanthema
Item
General rash/exanthema
boolean
If YES, please complete the Rash/Exanthema form
Item
If YES, please complete the Rash/Exanthema form
text
Item Group
Symptom 3
Parotid/Salivary gland swelling
Item
Parotid/Salivary gland swelling
boolean
If YES, please complete the Parotid/Salivary Gland Swelling form
Item
If YES, please complete the Parotid/Salivary Gland Swelling form
text
Item Group
Symptom 4
Febrile convulsions - suspected signs of meningitis
Item
Febrile convulsions - suspected signs of meningitis
boolean
If Yes, please complete the Febrile Convulsions - Suspected Signs of Meningitis form
Item
If Yes, please complete the Febrile Convulsions - Suspected Signs of Meningitis form
text
Item Group
Please report serious adverse events to GSK by telephone within 24 hours
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