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Immunological responses after concomitant vaccination with the yellow fever-vaccine and the TBE-vaccine, or JE-vaccine

Phase 1
Conditions
Prevention of TBE or Japanece encephalitis by co-vaccination with the yellow fever vaccine
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Registration Number
EUCTR2017-002137-32-SE
Lead Sponsor
Hans-Gustaf Ljunggren
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
140
Inclusion Criteria

Individuals that need prevention of TBE, Yellow fever and JE
Induviduals that signed informed concent
Individuals between 18-55 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Individuals that:
Claim that they already had vaccination, or been infected with TBE, JE or Yellow fever
Are allergic to eggs or something else in FSME Immun, Stamaril and Ixiaro
Have an autoimmune disease
Have difficulties donating blood
Take drugs against cancer
Take corticosteroids
Have a disease that had affected the brain
Have neurological disorders
Have dampened immune function or that of other reason is evaluated by the investigator as inappropriate for inclusion
Have HCV or HIV
Had fever within a week from the time of vaccination
Are pregnant or plan to be pregnant in the course of the study
Have a bleeding disorder
Breastfeed
Participated in other clinical trials within the last three months
Cannot fulfill the study
Or for other reasons is evaluated not to be suitable for inclusion

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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