FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years

• ClinicalTrials.gov Identifier: NCT00161889
• Recruitment Status: Completed
• First Posted: September 13, 2005
• Last Update Posted: May 21, 2015
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: September 8, 2005
• First Posted Date: September 13, 2005
• Last Update Posted Date: May 21, 2015
• Study Start Date: February 2002
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years
• Official Title: 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double
• Condition: Encephalitis, Tick-borne
• Intervention: Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 12, 2005): 615
• Original Enrollment: Same as current
• Study Completion Date: August 2002
• Primary Completion Date: Not Provided

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 16 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00161889
• Other Study ID Numbers: 207
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Principal Investigator: Baxter BioScience Investigator; Baxter Healthcare Corporation

• PRS Account: Pfizer
• Verification Date: May 2015