Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

Open-Label, Follow-up, Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated Using a Rapid Immunization Schedule (Follow-up to Study 225)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00163540

Enrollment

Unknown

Registered

2005-09-14

Start date

2005-05-31

Completion date

2005-06-30

Last updated

2015-05-21

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

Conditions

Encephalitis, Tick-borne

Keywords

tick-borne encephalitis

Brief summary

The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.

Interventions

BIOLOGICALFormaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to 66 Years

Healthy volunteers

Yes

Inclusion criteria

* Male and female subjects who: * received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225 * understand the nature of the study, agree to its provisions and provide written informed consent * are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the clinical trial) * have a negative pregnancy test result at the first medical examination (if female and capable of bearing children) * agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children) * agree to keep a Subject Diary

Exclusion criteria

Subjects who: * have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225 * have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis) * have had an allergic reaction to one of the components of the vaccine since participation in Study 225 * suffer from a disease (e.g. autoimmune disease, immunodeficiency) or are undergoing a form of treatment (e.g., systemic corticosteroids) that can be expected to influence immunological functions * have a known or suspected problem with drug or alcohol abuse (\>4 liters wine/week or equivalent doses of other alcoholic beverages) * have donated blood or plasma within 30 days of study entry * have received a blood transfusion or immunoglobulins within 30 days of study entry * are known to be HIV positive (an HIV test is not required specifically for this study) * are simultaneously participating in another clinical trial including administration of an investigational product * have participated in any other clinical study within 6 weeks prior to study start * have participated in another Baxter vaccine study in the past 6 months (with the exception of follow-up studies) * For female subjects: pregnancy or lactation

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026