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

NCT00161785 | Completed Phase 4

• 1 other identifier: 223
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess:

• TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN 0.5ml by means of ELISA and neutralization test (NT).
• TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA and NT.

Conditions

Tick-borne Encephalitis

Interventions

FSME-IMMUN 0.5ml BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects will be eligible for participation in this study if:
• they understand the nature of the study, agree to its provisions and provide written informed consent;
• they received the third vaccination with FSME-IMMUN 0.5ml during the course of Baxter Study 213;
• blood was drawn before and after their third vaccination during the course of Baxter Study 213;
• they showed an ELISA-concentration \> 126 VIE U/ml and / or a NT-titer \>= 1:10 after the third vaccination in Baxter Study 213;
• they agree to keep a Subject Diary.

You may not qualify if:

• Subjects will be excluded from participation in this study if they:
• received any TBE vaccination since their third vaccination with FSME-IMMUN 0.5ml;
• received a vaccination against yellow fever and / or Japanese B-encephalitis since their third vaccination with FSME-IMMUN 0.5ml;
• are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.5ml;
• have a known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level of other alcoholic beverages);
• have received a blood transfusion or immunoglobulins within one month to the first and second blood draw;
• have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies).
• Subjects will not be eligible for booster vaccination if:
• they are not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial);
• they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
• they have donated blood or plasma within one month to the booster vaccination;
• female of childbearing potential are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination);
• they have shown an allergic reaction to one of the components of the vaccine since their third vaccination in Baxter Study 213;
• they are simultaneously participating in another clinical trial including administration of an investigational product within six weeks prior to the booster vaccination until the end of the study.
• Subjects who have received any vaccination within two weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Hospital in Debica - Zespo Opieki Zdrowotnej w Debicy

Dębica, 33-200, Poland

Location

Szpital Jana Pawla II Oddzial Neuroinfekcji

Krakow, 31-202, Poland

Location

MeSH Terms

Conditions

Encephalitis, Tick-Borne

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Tick-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Ryszard Konior, MD

  Szpital Jana Pawla II Oddzial Neuroinfekcji, Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 13, 2005
• Study Start: June 1, 2004
• Study Completion: July 1, 2005
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

PL (2)