Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

Pfizer

Status and phase

Completed

Phase 4

Conditions

Encephalitis, Tick-borne

Treatments

Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161954

225

Details and patient eligibility

About

The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.

Sex

All

Ages

16 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Understanding the nature of the study, agreement to its provisions and written informed consent
Written informed consent of subject´s parents / legal guardians (if subject is under 18 years of age)
Aged >= 16 years (from the 16th birthday) to <= 65 years (to the last day before the 66th birthday)
Clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial)
Negative pregnancy test result at the first medical examination (if female and capable of bearing children)
Agreeing to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)
Agreeing to keep a subject diary.

Exclusion criteria

History of any previous TBE vaccination
History of TBE infection
History of infection with other flaviviruses
History of vaccination against yellow fever and/or Japanese B-encephalitis
History of allergic reactions, in particular to one of the components of the vaccine
Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
Known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
Donation of blood or plasma within one month of study start
Having received a blood transfusion or immunoglobulins within one month of study entry
HIV positivity (an HIV test is not required specifically for the purpose of this study
Simultaneous participation in another clinical trial including administration of an investigational product
Participating in any other clinical study within six weeks prior to study start
Participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
Pregnancy or lactation (if female)
Having received any other vaccination within two weeks prior to study entry