ID
33074
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)
- 22.11.18 22.11.18 -
- 26.11.18 26.11.18 -
Rechteinhaber
GSK group of companies
Hochgeladen am
26. November 2018
DOI
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Lizenz
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
Eligibility Criteria
- StudyEvent: ODM
Beschreibung
Eligibility Question
Beschreibung
Did the subject meet all the entry criteria?
Datentyp
boolean
Beschreibung
Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below
Datentyp
text
Beschreibung
Inclusion Criteria
Beschreibung
Exclusion Criteria
Beschreibung
tick Yes, if disqualified, tick No, if not disqualified
Datentyp
text
Beschreibung
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Datentyp
boolean
Beschreibung
For corticosteroids this will mean prednisone, or equivalet, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed
Datentyp
boolean
Beschreibung
Planned administration/administration of a vaccine not forseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12)
Datentyp
boolean
Beschreibung
Previous vaccination against measles, mumps, rubella and/or varicella
Datentyp
boolean
Beschreibung
History of measles, mumps, rubella and/or varicella/zoster diseases
Datentyp
boolean
Beschreibung
Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial
Datentyp
boolean
Beschreibung
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
Datentyp
boolean
Beschreibung
A family history of congenital or hereditary immunodeficiency
Datentyp
boolean
Beschreibung
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Datentyp
boolean
Beschreibung
Major congenital defects or serious chronic illness
Datentyp
boolean
Beschreibung
History of any neurologic disorders or seizures
Datentyp
boolean
Beschreibung
high-risk persons: new-born infants (0-4 weeks of age); pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox; persons with known immunodeficiency
Datentyp
boolean
Beschreibung
The presence of a moderate or severe illness with or without fever. All vaccines cn be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C/ rectal temperature <38°C.
Datentyp
boolean
Beschreibung
Rectal temperature >= 38°C or axillary temperature >=37.5°C at the time of vaccination
Datentyp
boolean
Beschreibung
Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period
Datentyp
boolean
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Eligibility Criteria
- StudyEvent: ODM
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