Trial record 19 of 32 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 29, 2014
Central Nervous System Viral Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
RNA Virus Infections