ID

33063

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-11-23 2018-11-23 -
  2. 2018-11-26 2018-11-26 -
Rättsinnehavare

GSK group of companies

Uppladdad den

26 november 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

Engelsk

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

1 Formulär  
Administrative data
Beskrivning

Administrative data

Visit Number
Beskrivning

Visit Number

Datatyp

text

Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Subject Number
Beskrivning

Subject Number

Datatyp

integer

General Symptoms
Beskrivning

General Symptoms

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

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

Datatyp

text

General Symptom 1
Beskrivning

General Symptom 1

Fever
Beskrivning

Fever

Datatyp

boolean

In any case, please complete the Temperature form
Beskrivning

In any case, please complete the Temperature form

Datatyp

text

Symptom 2
Beskrivning

Symptom 2

General rash/exanthema
Beskrivning

General rash/exanthema

Datatyp

boolean

If YES, please complete the Rash/Exanthema form
Beskrivning

If YES, please complete the Rash/Exanthema form

Datatyp

text

Symptom 3
Beskrivning

Symptom 3

Parotid/Salivary gland swelling
Beskrivning

Parotid/Salivary gland swelling

Datatyp

boolean

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

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

Datatyp

text

Symptom 4
Beskrivning

Symptom 4

Febrile convulsions - suspected signs of meningitis
Beskrivning

Febrile convulsions - suspected signs of meningitis

Datatyp

boolean

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

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

Datatyp

text

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

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

Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial