Status:
COMPLETED
Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule
Lead Sponsor:
Pfizer
Conditions:
Encephalitis, Tick-Borne
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 vaccin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00460486
Start Date
September 1 2006
Last Update
April 19 2023
Active Locations (4)
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1
Centrum Badan Farmakologii Klinicznej monipol
Krakow, Poland, 30-969
2
Niepubliczny ZOZ "Atarax" s.c.
Olsztyn, Poland, 10-117
3
Niepubliczny ZOZ "VITA"
Olsztyn, Poland, 10-295
4
"PANTAMED" Sp. z o.o.
Olsztyn, Poland, 10-461