Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

Encephalitis, Tick-borne Clinical Trial

Official title:

Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163618
• Other study ID #: 700501
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: May 20, 2015
• Start date: June 2005
• Est. completion date: July 2006

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Observational

Clinical Trial Summary

The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• Male and female children who participated in Study 146A if:

• they and/or their parents/legal guardians understand the nature of the study and agree to its provisions

• written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians

• they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A

• they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A

Exclusion Criteria:

• Subjects who received any further TBE vaccination since their first TBE booster vaccination

• Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A

• Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination

• Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A

• Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry

Study Design

N/A

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
Austria	Bahnhofstraße 9	Hermagor
Austria	Freistädter Strasse 290	Linz
Austria	Conrad-von-Hoetzendorf-Strasse	Voitsberg
Austria	Grieskirchner Strasse 17	Wels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Austria,