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

Encephalitis, Tick-Borne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460486
• Other study ID #: 690601
• Status: Completed
• Phase: Phase 3
• Start date: September 2006

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Tick-Borne

Intervention

Biological:
• Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

Locations

Country	Name	City	State
Poland	Centrum Badan Farmakologii Klinicznej monipol	Krakow
Poland	"PANTAMED" Sp. z o.o.	Olsztyn
Poland	Niepubliczny ZOZ "Atarax" s.c.	Olsztyn
Poland	Niepubliczny ZOZ "VITA"	Olsztyn

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.