ID

33063

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

Mots-clés

Versions (2)
  1. 23/11/2018 23/11/2018 -
  2. 26/11/2018 26/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

26 novembre 2018

DOI

Pour une demande vous connecter.

Licence

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

Anglais

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

1 Formulaires  
Administrative data
Description

Administrative data

Visit Number
Description

Visit Number

Type de données

text

Date of Visit
Description

Date of Visit

Type de données

date

Subject Number
Description

Subject Number

Type de données

integer

General Symptoms
Description

General Symptoms

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

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

Type de données

text

General Symptom 1
Description

General Symptom 1

Fever
Description

Fever

Type de données

boolean

In any case, please complete the Temperature form
Description

In any case, please complete the Temperature form

Type de données

text

Symptom 2
Description

Symptom 2

General rash/exanthema
Description

General rash/exanthema

Type de données

boolean

If YES, please complete the Rash/Exanthema form
Description

If YES, please complete the Rash/Exanthema form

Type de données

text

Symptom 3
Description

Symptom 3

Parotid/Salivary gland swelling
Description

Parotid/Salivary gland swelling

Type de données

boolean

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

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

Type de données

text

Symptom 4
Description

Symptom 4

Febrile convulsions - suspected signs of meningitis
Description

Febrile convulsions - suspected signs of meningitis

Type de données

boolean

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

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

Type de données

text

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

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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