Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

Encephalitis, Tick-borne Clinical Trial

Official title:

Open-Label, Follow-up, Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated Using a Rapid Immunization Schedule (Follow-up to Study 225)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163540
• Other study ID #: 690501
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: May 20, 2015
• Start date: May 2005
• Est. completion date: June 2005

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 investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 66 Years

Eligibility

Inclusion Criteria:

• Male and female subjects who:

• received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225

• understand the nature of the study, agree to its provisions and provide written informed consent

• are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the 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 who:

• have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225

• have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis)

• have had an allergic reaction to one of the components of the vaccine since participation in Study 225

• suffer from a disease (e.g. autoimmune disease, immunodeficiency) 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 doses 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 this study)

• are simultaneously participating in another clinical trial including administration of an investigational product

• have participated in any other clinical study within 6 weeks prior to study start

• have participated in another Baxter vaccine study in the past 6 months (with the exception of follow-up studies)

• For female subjects: pregnancy or lactation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne

Intervention

Biological:
• Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

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,