ID

33063

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 (2)
  1. 23.11.18 23.11.18 -
  2. 26.11.18 26.11.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

26. November 2018

DOI

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Immunogenicity of Combined Measles Mumps Rubella Varicella Vaccine for healthy 2 y.o children - 104020

Englisch

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

1 Formulare  
Administrative data
Beschreibung

Administrative data

Visit Number
Beschreibung

Visit Number

Datentyp

text

Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Subject Number
Beschreibung

Subject Number

Datentyp

integer

General Symptoms
Beschreibung

General Symptoms

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

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

Datentyp

text

General Symptom 1
Beschreibung

General Symptom 1

Fever
Beschreibung

Fever

Datentyp

boolean

In any case, please complete the Temperature form
Beschreibung

In any case, please complete the Temperature form

Datentyp

text

Symptom 2
Beschreibung

Symptom 2

General rash/exanthema
Beschreibung

General rash/exanthema

Datentyp

boolean

If YES, please complete the Rash/Exanthema form
Beschreibung

If YES, please complete the Rash/Exanthema form

Datentyp

text

Symptom 3
Beschreibung

Symptom 3

Parotid/Salivary gland swelling
Beschreibung

Parotid/Salivary gland swelling

Datentyp

boolean

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

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

Datentyp

text

Symptom 4
Beschreibung

Symptom 4

Febrile convulsions - suspected signs of meningitis
Beschreibung

Febrile convulsions - suspected signs of meningitis

Datentyp

boolean

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

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

Datentyp

text

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

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

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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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