Status:
COMPLETED
FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years
Lead Sponsor:
Pfizer
Conditions:
Encephalitis, Tick-borne
Eligibility:
All Genders
6-16 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all volunteers who completed two vacci...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- All volunteers who participated in Baxter study 205 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:
- They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 205
- They and/or their legal guardian understand the nature of the study, agree to its provisions and give written informed consent
- Exclusion Criteria:
- There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.
- Volunteers will be excluded from vaccination and consecutive visits in this study if they:
- Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
- Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 205
- Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 205
- 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
- Have received banked human blood or immunoglobulins within one month of study entry
- Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 205
- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 205
- Had received an investigational new drug within 6 weeks prior to study start
- If female and capable of bearing children - have a positive pregnancy test at the first medical examination
Exclusion
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2002
Estimated Enrollment :
615 Patients enrolled
Trial Details
Trial ID
NCT00161889
Start Date
February 1 2002
End Date
August 1 2002
Last Update
May 21 2015
Active Locations (19)
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1
Neuschwanstein Strasse 5
Augsburg, Germany, D-86163
2
Marktplatz 33
Bad Saulgau, Germany, D-88348
3
Hauptstrasse 9
Bietigheim-Bissingen, Germany, D-74321
4
Salzgasse 11
Calw, Germany, D-75365