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.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00460486
First received: April 13, 2007
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

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: 330
Study Start Date: September 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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

Locations
Poland
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
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator, MD Baxter BioScience
  More Information

No publications provided

Responsible Party: Katrin Koelling Schlebusch, Clinical Project Manager, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00460486     History of Changes
Other Study ID Numbers: 690601
Study First Received: April 13, 2007
Last Updated: March 27, 2008
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on October 19, 2014