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

Encephalitis, Tick-borne Clinical Trial

Official title:

Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161954
• Other study ID #: 225
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: May 20, 2015
• Start date: March 2004
• Est. completion date: May 2004

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne

Intervention

Biological:
• Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Locations

Country	Name	City	State
Belgium	SGS Biopharma Research Unit Stuivenberg	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium,