You are here

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

Last updated on November 7, 2019

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Encephalitis, Tick-Borne
Intervention  ICMJE Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: April 13, 2007)
330
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion DateNovember 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00460486
Other Study ID Numbers  ICMJE 690601
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Baxter BioScience Investigator, MDBaxter BioScience
PRS AccountPfizer
Verification DateMay 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now