NCT Number: 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
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.
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Notify MeKey information
Conditions
Age range
7 year–11 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Bahnhofstraße 9, Hermagor, Austria
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Pfizer
Industry
Registry information
Official study 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
Important dates
- Study start
- 2005
- Study completion
- 2006
- 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.
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