FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years
Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 6 to 16 Years
1 other identifier
interventional
615
1 country
19
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 vaccinations in one of the three treatment groups of Baxter study 205 (safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16 years).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2002
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedMay 21, 2015
May 1, 2015
September 8, 2005
May 20, 2015
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (19)
Neuschwanstein Strasse 5
Augsburg, D-86163, Germany
Marktplatz 33
Bad Saulgau, D-88348, Germany
Hauptstrasse 9
Bietigheim-Bissingen, D-74321, Germany
Salzgasse 11
Calw, D-75365, Germany
Mohrenstrasse 8
Coburg, D-96450, Germany
Bahnhofstrasse 1
Elzach, D-79215, Germany
Rheinstrasse 1a
Ettenheim, D-77955, Germany
Peter-Seifert Strasse 5
Gersfeld, D-36129, Germany
Solothumer Strasse 2
Heilbronn, D-74072, Germany
Hauptstrasse 240
Kehl, D-77694, Germany
Schwarzwald Strasse 20
Kirchzarten, D-79199, Germany
Altoettinger Strasse 3
Landsberg, D-86899, Germany
Rastatter Strasse 7
Mannheim-Secken, 68239, Germany
Wilhelmstrasse 25
Metzingen, D-72555, Germany
Dohmbuehler Strasse 8
Nuremberg, D-90449, Germany
Wilhelmstrasse 7
Offenburg, D-77654, Germany
Berneckstrasse 19
Schramberg, D-78713, Germany
Hauptstrasse 11
Tegernsee, D-83681, Germany
Broner Platz 6
Weingarten, D-88250, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baxter BioScience Investigator
Baxter Healthcare Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 13, 2005
Study Start
February 1, 2002
Study Completion
August 1, 2002
Last Updated
May 21, 2015
Record last verified: 2015-05