ID

32982

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

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Versionen (1)
  1. 22.11.18 22.11.18 -
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GSK group of companies

Hochgeladen am

22. 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

Englisch

Elimination Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Elimination Criteria
Note
Beschreibung

Note

Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis
Beschreibung

Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis

Datentyp

text

Elimination Criteria
Beschreibung

Elimination Criteria

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Beschreibung

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Elimination Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Elimination Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Note
Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis
Item
Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis
text
Item Group
Elimination Criteria
Item
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text
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Code List
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CL Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period. (1)
CL Item
Newly diagnosed immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, during the study period (2)
CL Item
Administration of a licensed vaaccine not foreseen in the study protocol during the study (30 days prior to the first vaccicnation until study end(Week 12)). (3)
CL Item
Chronic administration (defined as more than 14 days) of immunosuppresants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) (4)
CL Item
Administration of immunoglobulins and/or any blood products during the study period. (5)
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