NCT00163540

CompletedPhase 4

Immunogenicity and Safety Study of a Third Vaccination With ...

Pfizer Source

Pfizer

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

690501

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

June 2005

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: June 2005
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2005
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
June 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 8, 2005
Actual (reported)
First Posted
September 14, 2005
Actual (reported)

Last Updated: May 21, 2015
Status Verified: May 2015
Last Update Submitted: May 20, 2015

Conditions

Encephalitis, Tick-borne

Keywords

tick-borne encephalitis

Interventions

Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain NeudörflBiological

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age17 Years - 66 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Male and female subjects who:
received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225

Sponsors & Collaborators

Pfizer
Industrylead

Study Sites (1)

SGS Biopharma Research Unit Stuivenberg

Antwerp, 2060, Belgium

Related Publications (1)

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.
PMID: 21592984DERIVED

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesTick-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitis

Study Officials

Baxter BioScience Investigator, MD
Baxter BioScience
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 14, 2005

Study Start

May 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

June 2005

Date type not reported

Completed

NCT00161785

Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years

Phase 4Completed

NCT00503529

TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)

Phase 4Completed

NCT00894686

Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

Phase 4Completed

NCT01582698

TBE Seropersistence up to 10 Years After First Booster in Adults

Phase 4Completed

NCT00311441

Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

Phase 4Completed

NCT00452621

Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years

Phase 4Completed

understand the nature of the study, agree to its provisions and provide written informed consent

are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the clinical trial)

have a negative pregnancy test result at the first medical examination (if female and capable of bearing children)

agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)

agree to keep a Subject Diary

You may not qualify if:

Subjects who:
have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225
have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis)
have had an allergic reaction to one of the components of the vaccine since participation in Study 225
suffer from a disease (e.g. autoimmune disease, immunodeficiency) or are undergoing a form of treatment (e.g., systemic corticosteroids) that can be expected to influence immunological functions
have a known or suspected problem with drug or alcohol abuse (\>4 liters wine/week or equivalent doses of other alcoholic beverages)
have donated blood or plasma within 30 days of study entry
have received a blood transfusion or immunoglobulins within 30 days of study entry
are known to be HIV positive (an HIV test is not required specifically for this study)
are simultaneously participating in another clinical trial including administration of an investigational product
have participated in any other clinical study within 6 weeks prior to study start
have participated in another Baxter vaccine study in the past 6 months (with the exception of follow-up studies)
For female subjects: pregnancy or lactation

Contact the study team to confirm eligibility.

Brain Diseases

Central Nervous System Diseases

Nervous System Diseases

Neuroinflammatory Diseases

This date has not been verified as actual or estimated.

Last Updated

May 21, 2015

Record last verified: 2015-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00163540
Data provider: ClinicalTrials.gov
Source updated: 2015-05-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:53 UTC

Locations

BE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations