ID

33073

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. 2018-11-22 2018-11-22 -
  2. 2018-11-26 2018-11-26 -
Rättsinnehavare

GSK group of companies

Uppladdad den

26 november 2018

DOI

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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

Engelsk

Medical History

1 Formulär  
  1. StudyEvent: ODM
    1. Medical History
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 Medical History / Physical Examination
Beskrivning

General Medical History / Physical Examination

Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Beskrivning

Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?

Datatyp

text

Cutaneous
Beskrivning

Cutaneous

Datatyp

text

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Eyes
Beskrivning

Eyes

Datatyp

text

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Ears-Nose-Throat
Beskrivning

Ears-Nose-Throat

Datatyp

text

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Cardiovascular
Beskrivning

Cardiovascular

Datatyp

text

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Respiratory
Beskrivning

Respiratory

Datatyp

text

Gastrointestinal
Beskrivning

Gastrointestinal

Datatyp

text

Muskuloskeletal
Beskrivning

Muskuloskeletal

Datatyp

text

Neurological
Beskrivning

Neurological

Datatyp

text

Genitourinary
Beskrivning

Genitourinary

Datatyp

text

Haematology
Beskrivning

Haematology

Datatyp

text

Allergies
Beskrivning

Allergies

Datatyp

text

Endocrine
Beskrivning

Endocrine

Datatyp

text

Other, specify
Beskrivning

Other, specify

Datatyp

text

Concomitant Medications
Beskrivning

Concomitant Medications

Please report medication(s) as specified in the protocol and fill in the Medication section
Beskrivning

Please report medication(s) as specified in the protocol and fill in the Medication section

Datatyp

text

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Similar models

Medical History

1 Formulär
  1. StudyEvent: ODM
    1. Medical History
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 Medical History / Physical Examination
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
text
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Code List
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
CL Item
No (1)
CL Item
Yes -> please tick appropriate box(es) and give diagnosis (2)
Item
Cutaneous
text
Cutaneous
Code List
Cutaneous
CL Item
Current (1)
CL Item
Past (2)
Diagnosis
Item
Diagnosis
text
Item
Eyes
text
Eyes
Code List
Eyes
CL Item
Current (1)
CL Item
Past (2)
Diagnosis
Item
Diagnosis
text
Item
Ears-Nose-Throat
text
Ears-Nose-Throat
Code List
Ears-Nose-Throat
CL Item
Current (1)
CL Item
Past (2)
Diagnosis
Item
Diagnosis
text
Item
Cardiovascular
text
Cardiovascular
Code List
Cardiovascular
CL Item
Current (1)
CL Item
Past (2)
Diagnosis
Item
Diagnosis
text
Item
Respiratory
text
Respiratory
Code List
Respiratory
CL Item
Current (1)
CL Item
Past (2)
Item
Gastrointestinal
text
Gastrointestinal
Code List
Gastrointestinal
CL Item
Current (1)
CL Item
Past (2)
Item
Muskuloskeletal
text
Muskuloskeletal
Code List
Muskuloskeletal
CL Item
Current (1)
CL Item
Past (2)
Item
Neurological
text
Neurological
Code List
Neurological
CL Item
Current (1)
CL Item
Past (2)
Item
Genitourinary
text
Genitourinary
Code List
Genitourinary
CL Item
Current (1)
CL Item
Past (2)
Item
Haematology
text
Haematology
Code List
Haematology
CL Item
Current (1)
CL Item
Past (2)
Item
Allergies
text
Allergies
Code List
Allergies
CL Item
Current (1)
CL Item
Past (2)
Item
Endocrine
text
Endocrine
Code List
Endocrine
CL Item
Current (1)
CL Item
Past (2)
Other, specify
Item
Other, specify
text
Item Group
Concomitant Medications
Please report medication(s) as specified in the protocol and fill in the Medication section
Item
Please report medication(s) as specified in the protocol and fill in the Medication section
text
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