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)

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.

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Key information

Conditions

Encephalitis, Tick-borne Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Tick-Borne Diseases Vector Borne Diseases Virus Diseases

Age range

17 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SGS Biopharma Research Unit Stuivenberg

Antwerp, 2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

Biological

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start: 2005
Study completion: 2005
First posted: Sep 14, 2005
Registry last updated: May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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