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

Phase 4

Completed

• Conditions: Encephalitis, Tick-borne

• Registration Number: NCT00161954
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study Completion: 2004-05
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-13
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

SGS Biopharma Research Unit Stuivenberg; 🇧🇪 Antwerp, Belgium