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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002137-32-SE

Enrollment

140

Registered

2017-07-07

Start date

2017-09-05

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of TBE or Japanece encephalitis by co-vaccination with the yellow fever vaccine

Interventions

Trade Name: Stamaril Pharmaceutical Form: Suspension for injection Trade Name: FSME Immun Pharmaceutical Form: Suspension for injection in pre-filled s

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Not applicable;Primary end point(s): We expect to see higher number of plasmablasts, TBE and JE specific antibodies and a higher amount of specific CD8 and CD4 T cells against TBEV and JEV if these vaccines are administered simultaneously as the yellow fever vaccine;Timepoint(s) of evaluation of this end point: Last sampeling timepoint is 30 days (or 60 days) after the last vaccination. This sample will during later analyses be evaluated for levels of antibodies and specific T cells.;Main Objective: We will study if individuals that have recieved concomittant vaccinations with FSME Immun and Stamaril will generate a better immune response against TBE compared to individuals that only recieved FSME Immun. We will study if individuals that have recieved concomittant vaccinations with Ixiaro and Stamaril will generate a better immune response against JE compared to individuals that only recieved Ixiaro. The immune responses generated in the groups that recieved concomittant vaccinations will in a later stage be compared with each other.	—

Measure

Time frame

Secondary Objective: Not applicable;Primary end point(s): We expect to see higher number of plasmablasts, TBE and JE specific antibodies and a higher amount of specific CD8 and CD4 T cells against TBEV and JEV if these vaccines are administered simultaneously as the yellow fever vaccine;Timepoint(s) of evaluation of this end point: Last sampeling timepoint is 30 days (or 60 days) after the last vaccination. This sample will during later analyses be evaluated for levels of antibodies and specific T cells.;Main Objective: We will study if individuals that have recieved concomittant vaccinations with FSME Immun and Stamaril will generate a better immune response against TBE compared to individuals that only recieved FSME Immun. We will study if individuals that have recieved concomittant vaccinations with Ixiaro and Stamaril will generate a better immune response against JE compared to individuals that only recieved Ixiaro. The immune responses generated in the groups that recieved concomittant vaccinations will in a later stage be compared with each other.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Sweden

Contacts

Public ContactKim Blom

Karolinska Institutet

kim.blom@ki.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026