Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

NCT ID: NCT00161954

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2004-05-31

Brief Summary

The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.

Conditions

Encephalitis, Tick-borne

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Understanding the nature of the study, agreement to its provisions and written informed consent
• Written informed consent of subject´s parents / legal guardians (if subject is under 18 years of age)
• Aged >= 16 years (from the 16th birthday) to <= 65 years (to the last day before the 66th birthday)
• Clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial)
• Negative pregnancy test result at the first medical examination (if female and capable of bearing children)
• Agreeing to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)
• Agreeing to keep a subject diary.

Exclusion Criteria

• History of any previous TBE vaccination
• History of TBE infection
• History of infection with other flaviviruses
• History of vaccination against yellow fever and/or Japanese B-encephalitis
• History of allergic reactions, in particular to one of the components of the vaccine
• Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
• Known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
• Donation of blood or plasma within one month of study start
• Having received a blood transfusion or immunoglobulins within one month of study entry
• HIV positivity (an HIV test is not required specifically for the purpose of this study
• Simultaneous participation in another clinical trial including administration of an investigational product
• Participating in any other clinical study within six weeks prior to study start
• Participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
• Pregnancy or lactation (if female)
• Having received any other vaccination within two weeks prior to study entry

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Baxter BioScience Investigator

Role: PRINCIPAL_INVESTIGATOR

Baxter BioScience

Locations

SGS Biopharma Research Unit Stuivenberg

Antwerp, , Belgium

Countries

Belgium

References

Orlinger KK, Hofmeister Y, Fritz R, Holzer GW, Falkner FG, Unger B, Loew-Baselli A, Poellabauer EM, Ehrlich HJ, Barrett PN, Kreil TR. A tick-borne encephalitis virus vaccine based on the European prototype strain induces broadly reactive cross-neutralizing antibodies in humans. J Infect Dis. 2011 Jun 1;203(11):1556-64. doi: 10.1093/infdis/jir122.

Reference Type: DERIVED

PMID: 21592984 (View on PubMed)

Other Identifiers

225

Identifier Type: -

Identifier Source: org_study_id