ID

33063

Beschrijving

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

Trefwoorden

Versies (2)
  1. 23-11-18 23-11-18 -
  2. 26-11-18 26-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

26 november 2018

DOI

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Licentie

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

Engels

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

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Visit Number
Beschrijving

Visit Number

Datatype

text

Date of Visit
Beschrijving

Date of Visit

Datatype

date

Subject Number
Beschrijving

Subject Number

Datatype

integer

General Symptoms
Beschrijving

General Symptoms

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

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

Datatype

text

General Symptom 1
Beschrijving

General Symptom 1

Fever
Beschrijving

Fever

Datatype

boolean

In any case, please complete the Temperature form
Beschrijving

In any case, please complete the Temperature form

Datatype

text

Symptom 2
Beschrijving

Symptom 2

General rash/exanthema
Beschrijving

General rash/exanthema

Datatype

boolean

If YES, please complete the Rash/Exanthema form
Beschrijving

If YES, please complete the Rash/Exanthema form

Datatype

text

Symptom 3
Beschrijving

Symptom 3

Parotid/Salivary gland swelling
Beschrijving

Parotid/Salivary gland swelling

Datatype

boolean

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

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

Datatype

text

Symptom 4
Beschrijving

Symptom 4

Febrile convulsions - suspected signs of meningitis
Beschrijving

Febrile convulsions - suspected signs of meningitis

Datatype

boolean

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

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

Datatype

text

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

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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