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)

Pfizer

Status and phase

Completed

Phase 4

Conditions

Encephalitis, Tick-borne

Treatments

Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00163540

690501

Details and patient eligibility

About

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.

Sex

All

Ages

17 to 66 years old

Volunteers

Accepts Healthy Volunteers

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