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 1 to 6 Years

Pfizer25 sites in 2 countries615 target enrollmentFebruary 2002

ConditionsEncephalitis, Tick-borne

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Encephalitis, Tick-borne
Sponsor: Pfizer
Enrollment: 615
Locations: 25
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

August 2002

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•All volunteers who participated in Baxter study 199 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 199
•Written informed consent from the legal guardian is available.

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 199
•Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
•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 199
•Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199
•Had received an investigational new drug within 6 weeks prior to study start