Is it possible to improve humoral response to TBE vaccine in elderly (50+ year olds) by means of changed dosage intervals/number of doses?

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003549-90-SE

Enrollment

250

Registered

2014-10-10

Start date

2014-11-24

Completion date

Unknown

Last updated

2014-12-01

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

Conditions

None listed

Interventions

Trade Name: FSME-IMMUN Product Name: FSME-IMMUN Pharmaceutical Form: Solution for injection Other descriptive name: TICK-BORNE ENCEPHALITIS VACCINE (INACTIVATED)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female subjects aged 50 or more for study group and 18-49 for control group 2. Written informed consent 3. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. 4. Available for all visits scheduled in this study. 5. No previous TBE vaccination 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. Previous TBE infection. 2. Previously immunized with TBE vaccine. 3. Anaphylactic reaction to egg protein. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator 4. Chronic administration of immunosuppressants or other immunemodifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed 5. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection 6. Pregnancy or lactation 7. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of =38 °C).

Design outcomes

Primary

Measure	Time frame
Main Objective: To study whether any differences remain before and one month after an additional dose at the following season.;Secondary Objective: To study whether an additional dose of TBE vaccine 2 months after the second dose will improve protection (determined as SCR and GMT) in an age group 50+.;Primary end point(s): Serum concentration of neutralising antibodies against TBE one month after an additional dose the following year.;Timepoint(s) of evaluation of this end point: One month after an additional dose the following year.	—

Measure

Time frame

Main Objective: To study whether any differences remain before and one month after an additional dose at the following season.;Secondary Objective: To study whether an additional dose of TBE vaccine 2 months after the second dose will improve protection (determined as SCR and GMT) in an age group 50+.;Primary end point(s): Serum concentration of neutralising antibodies against TBE one month after an additional dose the following year.;Timepoint(s) of evaluation of this end point: One month after an additional dose the following year.

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Secondary

Measure	Time frame
Secondary end point(s): Serum concentration of neutralising antibodies against TBE one month after two or three doses. ;Timepoint(s) of evaluation of this end point: One month after second or third doses.	—

Countries

Sweden

Outcome results