FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years
NCT00161850
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
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.
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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years | |||
| Official Title ICMJE | 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 | |||
| 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). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double | |||
| Condition ICMJE | Encephalitis, Tick-borne | |||
| Intervention ICMJE | Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 615 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | August 2002 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | 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:
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:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 1 Year to 6 Years (Child) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Austria, Germany | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00161850 | |||
| Other Study ID Numbers ICMJE | 206 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||