Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

NCT00460486 | Completed Phase 3 DMC

• 1 other identifier: 690601
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: \> 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.

Conditions

Encephalitis, Tick-Borne

Outcome Measures

Primary Outcomes (1)

• Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.

Interventions

Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), 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 (assent if the subjects is under 18 years of age);
• Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age);
• Are aged \>= 16 years (from the 16th birthday) at screening;
• Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a 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 will be excluded from participation in this study if they:
• Have a history of any previous tick-borne encephalitis (TBE) vaccination;
• Have a history of TBE infection;
• Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis);
• Have a history of allergic reactions, in particular to one of the components of the vaccine;
• 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;
• Have a known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level 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 the purpose of this study);
• Are simultaneously participating in another clinical trial including administration of an investigational product;
• Have participated in any other clinical study within six weeks prior to study entry;
• Are pregnant or breastfeeding (if female);
• Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
• Have received any other vaccination within two weeks prior to study entry.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Centrum Badan Farmakologii Klinicznej monipol

Krakow, 30-969, Poland

Location

Niepubliczny ZOZ "Atarax" s.c.

Olsztyn, 10-117, Poland

Location

Niepubliczny ZOZ "VITA"

Olsztyn, 10-295, Poland

Location

"PANTAMED" Sp. z o.o.

Olsztyn, 10-461, 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

• Baxter BioScience Investigator, MD

  Baxter BioScience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Start: September 1, 2006
• Primary Completion: November 1, 2007
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

PL (4)