Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.

Official Title
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Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Conditions
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Tick-borne Encephalitis

Intervention / Treatment
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* Biological: FSME-IMMUN NEW 0.25 ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female children and adolescents will be eligible for participation in this study if: they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday); they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial); their parents/legal guardians understand the nature of the study and agree to its provisions; written informed consent is available from both parents/legal guardians, for Germany/Austria: additional written informed consent is available for children older than 8 years they or their parents/legal guardians agree to keep a volunteer diary. For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria: - negative pregnancy test at study entry; Exclusion Criteria: Children and adolescents will be excluded from participation in this study if they: have a history of any TBE vaccination; have a history of TBE infection; have a history of allergic reactions to one of the components of the vaccine; suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions; are known to be HIV positive (a special HIV test is not required for the purpose of the study); have received banked blood or immunoglobulins within one month of study entry; have a history of vaccination against yellow fever and/or Japanese B-encephalitis; suffer from hemorrhagic diathesis; are participating simultaneously in another clinical trial; if female: are pregnant or breastfeeding. Volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature > 38°C) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal. Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place separately. If volunteers have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time. Volunteers who have a positive TBE antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: FSME-IMMUN NEW 0.25 ml|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |