ID

33063

Descrição

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

Palavras-chave

Versões (2)
  1. 23/11/2018 23/11/2018 -
  2. 26/11/2018 26/11/2018 -
Titular dos direitos

GSK group of companies

Transferido a

26 de novembro de 2018

DOI

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Licença

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

Inglês

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

1 Formulários  
Administrative data
Descrição

Administrative data

Visit Number
Descrição

Visit Number

Tipo de dados

text

Date of Visit
Descrição

Date of Visit

Tipo de dados

date

Subject Number
Descrição

Subject Number

Tipo de dados

integer

General Symptoms
Descrição

General Symptoms

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

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

Tipo de dados

text

General Symptom 1
Descrição

General Symptom 1

Fever
Descrição

Fever

Tipo de dados

boolean

In any case, please complete the Temperature form
Descrição

In any case, please complete the Temperature form

Tipo de dados

text

Symptom 2
Descrição

Symptom 2

General rash/exanthema
Descrição

General rash/exanthema

Tipo de dados

boolean

If YES, please complete the Rash/Exanthema form
Descrição

If YES, please complete the Rash/Exanthema form

Tipo de dados

text

Symptom 3
Descrição

Symptom 3

Parotid/Salivary gland swelling
Descrição

Parotid/Salivary gland swelling

Tipo de dados

boolean

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

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

Tipo de dados

text

Symptom 4
Descrição

Symptom 4

Febrile convulsions - suspected signs of meningitis
Descrição

Febrile convulsions - suspected signs of meningitis

Tipo de dados

boolean

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

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

Tipo de dados

text

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

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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