Clinical trial NCT00460486: Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Encephalitis, Tick-Borne
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-16
Enrollment: 330
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Centrum Badan Farmakologii Klinicznej monipol
city: Olsztyn
country: Poland
facility: Niepubliczny ZOZ "Atarax" s.c.
city: Olsztyn
country: Poland
facility: Niepubliczny ZOZ "VITA"
city: Olsztyn
country: Poland
facility: "PANTAMED" Sp. z o.o.
Study officials:
affiliation: Baxter BioScience
name: Baxter BioScience Investigator, MD
role: PRINCIPAL_INVESTIGATOR
References: