Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

Condition(s) targeted: Encephalitis, Tick-Borne

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

Phase: Phase 3

Status: Completed

Sponsored by: Baxter Healthcare Corporation

Official(s) and/or principal investigator(s):
Baxter BioScience Investigator, MD, Principal Investigator, Affiliation: Baxter BioScience

The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0. 5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.

Official title: Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older

Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

- Understand the nature of the study, agree to its provisions and provide written

informed consent (assent if the subjects is under 18 years of age);

- Provide the written informed consent of their parents / legal guardian (if the subject

is under 18 years of age);

- Are aged >= 16 years (from the 16th birthday) at screening;

- Are clinically healthy, (i. e. the physician would have no reservations vaccinating

with FSME-IMMUN 0. 5 ml outside the scope of a 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 will be excluded from participation in this study if they:

- Have a history of any previous tick-borne encephalitis (TBE) vaccination;

- Have a history of TBE infection;

- Have a history of infection with or vaccination against other flaviviruses (e. g.

dengue fever, yellow fever, Japanese B-encephalitis);

- Have a history of allergic reactions, in particular to one of the components of the

vaccine;

- Suffer from a disease (e. g. autoimmune disease) 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 level 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 the purpose

of this study);

- Are simultaneously participating in another clinical trial including administration of

an investigational product;

- Have participated in any other clinical study within six weeks prior to study entry;

- Are pregnant or breastfeeding (if female);

- Are a member of the team conducting this study or are in a dependent relationship with

the study investigator. Dependent relationships include close relatives (i. e., children, partner/spouse, siblings, parents) as well as employees of the investigator.

- Have received any other vaccination within two weeks prior to study entry.

Centrum Badan Farmakologii Klinicznej monipol, Krakow 30-969, Poland

"PANTAMED" Sp. z o.o., Olsztyn 10-461, Poland

Niepubliczny ZOZ "Atarax" s.c., Olsztyn 10-117, Poland

Niepubliczny ZOZ "VITA", Olsztyn 10-295, Poland

Starting date: September 2006
Last updated: March 27, 2008