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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00460486
Other study ID # 690601
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2006

Study information

Verified date April 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
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. completion date
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.

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Terminated NCT01031537 - Vaccine Study for Tick-Borne Encephalitis Virus (TBEV) Phase 2
Completed NCT00161824 - Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR Phase 3
Completed NCT00163540 - Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225) Phase 4
Completed NCT00161967 - TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209) Phase 4
Completed NCT00161876 - FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years Phase 3
Recruiting NCT03932448 - Fever After Tick Bite Study
Completed NCT00311441 - Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children Phase 4
Completed NCT00161954 - Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years Phase 4
Completed NCT00163618 - Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children Phase 4
Completed NCT00503529 - TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223) Phase 4
Completed NCT00840801 - Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children Phase 3
Completed NCT00452621 - Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years Phase 4
Completed NCT00311493 - Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults Phase 4
Completed NCT00161850 - FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years Phase 2
Completed NCT00161889 - FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years Phase 2
Completed 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 4
Completed NCT00161746 - Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years Phase 2/Phase 3