- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00163618
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
May 20, 2015 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hermagor, Austria, 9620
- Bahnhofstraße 9
-
Linz, Austria, 4040
- Freistädter Strasse 290
-
Voitsberg, Austria, 8570
- Conrad-von-Hoetzendorf-Strasse
-
Wels, Austria, 4600
- Grieskirchner Strasse 17
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
May 21, 2015
Last Update Submitted That Met QC Criteria
May 20, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Tick-Borne Diseases
- Encephalitis
- Encephalitis, Tick-Borne
- Anti-Infective Agents
- Disinfectants
- Formaldehyde
Other Study ID Numbers
- 700501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Encephalitis, Tick-borne
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH)TerminatedTick-Borne Disease | Encephalitis, Tick-Borne | Tick-Borne Encephalitis | Glycoprotein E, Flavivirus | NSI Protein, FlavivirusUnited States
-
Medical University of ViennaAustrian Science Fund (FWF)CompletedTick Borne EncephalitisAustria
-
PfizerCompletedTick-borne Encephalitis (TBE)Poland
-
Sykehuset TelemarkNorwegian Institute of Public Health; Oslo University Hospital; Sorlandet Hospital... and other collaboratorsRecruiting
-
PfizerCompleted
-
GlaxoSmithKlineNovartis VaccinesCompleted
-
Novartis VaccinesCompleted
-
National Institute of Allergy and Infectious Diseases...Johns Hopkins Bloomberg School of Public HealthCompletedTick-Borne EncephalitisUnited States
-
University Medical Centre LjubljanaUniversity of Ljubljana School of Medicine, SloveniaRecruiting
-
University of SurreyCompletedTick-Borne EncephalitisUnited Kingdom
Clinical Trials on Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
-
PfizerCompleted
-
PfizerCompleted