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

Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older

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.

Study Overview

• Status: Completed
• Conditions: Encephalitis, Tick-Borne
• Intervention / Treatment: Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

• Study Type: Interventional
• Enrollment: 330
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland, 30-969
    • Centrum Badan Farmakologii Klinicznej monipol
  • Olsztyn, Poland, 10-117
    • Niepubliczny ZOZ "Atarax" s.c.
  • Olsztyn, Poland, 10-295
    • Niepubliczny ZOZ "VITA"
  • Olsztyn, Poland, 10-461
    • "PANTAMED" Sp. z o.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Principal Investigator: Baxter BioScience Investigator, MD, Baxter BioScience

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: April 13, 2007
• First Submitted That Met QC Criteria: April 13, 2007
• First Posted (Estimate): April 16, 2007

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Tick-Borne Diseases; Encephalitis; Encephalitis, Tick-Borne; Anti-Infective Agents; Disinfectants; Formaldehyde
• Other Study ID Numbers: 690601