Trial record 19 of 31 for:
Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule
This study has been completed.
Information provided by:
Baxter Healthcare Corporation
First received: April 13, 2007
Last updated: March 27, 2008
Last verified: March 2008
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.
Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||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
Primary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||November 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460486
|Centrum Badan Farmakologii Klinicznej monipol
|Krakow, Poland, 30-969 |
|"PANTAMED" Sp. z o.o.
|Olsztyn, Poland, 10-461 |
|Niepubliczny ZOZ "Atarax" s.c.
|Olsztyn, Poland, 10-117 |
|Niepubliczny ZOZ "VITA"
|Olsztyn, Poland, 10-295 |
Baxter Healthcare Corporation
||Baxter BioScience Investigator, MD
No publications provided
||Katrin Koelling Schlebusch, Clinical Project Manager, Baxter Healthcare Corporation
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 13, 2007
||March 27, 2008
||Poland: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Central Nervous System Viral Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
RNA Virus Infections