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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00163618
Enrollment
Unknown
Registered
2005-09-14
Start date
2005-06-30
Completion date
2006-07-31
Last updated
2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalitis, Tick-borne

Keywords

tick-borne encephalitis

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.

Interventions

Sponsors

Pfizer
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
Yes

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026