FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6... | NCT00161889

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2002

Primary Completion Date

Not provided

Completion Date

Aug 2002

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2015

Last Update Posted Date

May 21, 2015Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

615

Name	Type	Description	Arm Group Labels	Other Names
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)	Biological

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Baxter BioScience Investigator	Baxter Healthcare Corporation	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Neuschwanstein Strasse 5		Augsburg		D-86163	Germany
Marktplatz 33

ID	Term
D004675	Encephalitis, Tick-Borne

Ancestor Terms

ID	Term
D004671	Encephalitis, Arbovirus
D018792	Encephalitis, Viral
D020805	Central Nervous System Viral Diseases
D002494	Central Nervous System Infections
D007239	Infections
D000069544	Infectious Encephalitis
D001102	Arbovirus Infections
D000079426	Vector Borne Diseases
D017282	Tick-Borne Diseases
D014777	Virus Diseases
D012327	RNA Virus Infections
D018177	Flavivirus Infections
D018178	Flaviviridae Infections
D004660	Encephalitis
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000090862	Neuroinflammatory Diseases

ID	Term
D001688	Biological Products
D045424	Complex Mixtures