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

NCT00163618 | Completed

• 1 other identifier: 700501
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Encephalitis, Tick-borne

Keywords

tick-borne encephalitis

Interventions

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

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Bahnhofstraße 9

Hermagor, 9620, Austria

Location

Freistädter Strasse 290

Linz, 4040, Austria

Location

Conrad-von-Hoetzendorf-Strasse

Voitsberg, 8570, Austria

Location

Grieskirchner Strasse 17

Wels, 4600, Austria

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

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

Study Officials

• Baxter BioScience Investigator

  Baxter Healthcare Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 14, 2005
• Study Start: June 1, 2005
• Study Completion: July 1, 2006
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

AU (4)