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Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Centrum Badan Farmakologii Klinicznej monipol
Krakow, , 30-969 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-Borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00460486
Pfizer
Completed
Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

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Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Encephalitis, Tick-Borne
Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
Not Provided
November 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT00460486
690601
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Principal Investigator: Baxter BioScience Investigator, MD Baxter BioScience
Pfizer
May 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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