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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Encephalitis, Tick-Borne

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00460486

690601

Details and patient eligibility

About

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.

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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.