Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule
NCT00460486
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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Descriptive Information | ||||
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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 Summary | 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. | |||
Detailed Description | Not 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 | 330 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | November 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:
Exclusion Criteria: Subjects will be excluded from participation in this study if they:
| |||
Sex/Gender ICMJE |
| |||
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 Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |