Immunogenicity and Safety Study of a Rapid Immunization S... | NCT00161954

Studies
Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

NCT00161954

Sponsor

Pfizer

Status

Completed

Last Update Posted

May 21, 2015Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Encephalitis, Tick-borne

Interventions

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Mar 2004

Primary Completion Date

Not provided

Completion Date

May 2004

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

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Understanding the nature of the study, agreement to its provisions and written informed consent
Written informed consent of subject´s parents / legal guardians (if subject is under 18 years of age)
Aged >= 16 years (from the 16th birthday) to <= 65 years (to the last day before the 66th birthday)
Clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial)
Negative pregnancy test result at the first medical examination (if female and capable of bearing children)
Agreeing to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)
Agreeing to keep a subject diary.

Exclusion Criteria:

History of any previous TBE vaccination
History of TBE infection
History of infection with other flaviviruses
History of vaccination against yellow fever and/or Japanese B-encephalitis
History of allergic reactions, in particular to one of the components of the vaccine
Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
Known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
Donation of blood or plasma within one month of study start
Having received a blood transfusion or immunoglobulins within one month of study entry
HIV positivity (an HIV test is not required specifically for the purpose of this study
Simultaneous participation in another clinical trial including administration of an investigational product
Participating in any other clinical study within six weeks prior to study start
Participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
Pregnancy or lactation (if female)
Having received any other vaccination within two weeks prior to study entry

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Baxter BioScience Investigator	Baxter BioScience	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
SGS Biopharma Research Unit Stuivenberg		Antwerp		2060	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21592984	Derived	Orlinger KK, Hofmeister Y, Fritz R, Holzer GW, Falkner FG, Unger B, Loew-Baselli A, Poellabauer EM, Ehrlich HJ, Barrett PN, Kreil TR. A tick-borne encephalitis virus vaccine based on the European prototype strain induces broadly reactive cross-neutralizing antibodies in humans. J Infect Dis. 2011 Jun 1;203(11):1556-64. doi: 10.1093/infdis/jir122.

ID	Term
D004671	Encephalitis, Arbovirus
D018792	Encephalitis, Viral
D020805	Central Nervous System Viral Diseases
D002494	Central Nervous System Infections

ID	Term
D001688	Biological Products
D045424	Complex Mixtures