ID

33064

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

Klinische Studie, Phase III [Dokumenttyp]

Measles-Mumps-Rubella Vaccine

23-11-18 23-11-18 -
26-11-18 26-11-18 -

Houder van rechten

GSK group of companies

Geüploaded op

26 november 2018

DOI

Voor een aanvraag inloggen.

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

model
Details

Solicited Adverse Events (Group Priorix+Varilrix)

StudyEvent: ODM
1. Solicited Adverse Events (Group Priorix+Varilrix)

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Administrative data

Item Group

Administrative data

Item

Visit Number

text

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

Local Symptoms

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

Item

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

text

Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?

Code List

Has the subject experienced any of the following signs/symptoms at the administration site 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 NO/YES for each symptom. (4)

Priorix Vaccine - Local Symptoms

Item Group

Local Symptoms

Redness

Item

Redness

boolean

Size - Day 0

Item

Size - Day 0

float

Size - Day 1

Item

Size - Day 1

float

Size - Day 2

Item

Size - Day 2

float

Size - Day 3

Item

Size - Day 3

float

Ongoing after Day 3?

Item

Ongoing after Day 3?

boolean

If YES, record date of last day of symptoms

Item

If YES, record date of last day of symptoms

date

Priorix Vaccine - Local Symptoms

Item Group

Priorix Vaccine - Local Symptoms

Swelling

Item

Swelling

boolean

Size - Day 0

Item

Size - Day 0

float

Size - Day 1

Item

Size - Day 1

float

Size - Day 2

Item

Size - Day 2

float

Size - Day 3

Item

Size - Day 3

float

Ongoing after Day 3?

Item

Ongoing after Day 3?

boolean

If YES, record date of last day of symptoms

Item

If YES, record date of last day of symptoms

date

Priorix Vaccine - Local Symptoms

Item Group

Priorix Vaccine - Local Symptoms

Pain

Item

Pain

boolean

Intensity - Day 0

Item

Intensity - Day 0

integer

Intensity - Day 0

Code List

Intensity - Day 0

CL Item

None (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Intensity - Day 1

Item

Intensity - Day 1

integer

Intensity - Day 1

Code List

Intensity - Day 1

CL Item

None (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Intensity - Day 2

Item

Intensity - Day 2

integer

Intensity - Day 2

Code List

Intensity - Day 2

CL Item

None (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Intensity - Day 3

Item

Intensity - Day 3

integer

Intensity - Day 3

Code List

Intensity - Day 3

CL Item

None (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Ongoing after Day 3?

Item

Ongoing after Day 3?

boolean

If YES, record date of last day of symptoms

Item

If YES, record date of last day of symptoms

date

Varilrix Vaccine - Local Symptoms

Item Group

Varilrix Vaccine - Local Symptoms

Redness

Item

Redness

boolean

Size - Day 0

Item

Size - Day 0

float

Size - Day 1

Item

Size - Day 1

float

Size - Day 2

Item

Size - Day 2

float

Size - Day 3

Item

Size - Day 3

float

Ongoing after Day 3?

Item

Ongoing after Day 3?

boolean

If YES, record date of last day of symptoms

Item

If YES, record date of last day of symptoms

date

Varilrix Vaccine - Local Symptoms

Item Group

Varilrix Vaccine - Local Symptoms

Swelling

Item

Swelling

boolean

Size - Day 0

Item

Size - Day 0

float

Size - Day 1

Item

Size - Day 1

float

Size - Day 2

Item

Size - Day 2

float

Size - Day 3

Item

Size - Day 3

float

Ongoing after Day 3?

Item

Ongoing after Day 3?

boolean

If YES, record date of last day of symptoms

Item

If YES, record date of last day of symptoms

date

Varilrix Vaccine - Local Symptoms

Item Group

Varilrix Vaccine - Local Symptoms

Pain

Item

Pain

boolean

Intensity - Day 0

Item

Intensity - Day 0

integer

Intensity - Day 0

Code List

Intensity - Day 0

CL Item

None (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Intensity - Day 1

Item

Intensity - Day 1

integer

Intensity - Day 1

Code List

Intensity - Day 1

CL Item

None (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Intensity - Day 2

Item

Intensity - Day 2

integer

Intensity - Day 2

Code List

Intensity - Day 2

CL Item

None (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Intensity - Day 3

Item

Intensity - Day 3

integer

Intensity - Day 3

Code List

Intensity - Day 3

CL Item

None (1)

CL Item

Mild (2)

CL Item

Moderate (3)

CL Item

Severe (4)

Ongoing after Day 3?

Item

Ongoing after Day 3?

boolean

If YES, record date of last day of symptoms

Item

If YES, record date of last day of symptoms

date

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