Encephalitis, Tick-Borne Clinical Trial
Official title:
Open-label Phase IV Study to Investigate the Seropersistence of Tick Borne Encephalitis (TBE) Virus Antibodies After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults (Follow Up to Study 223)
Verified date | May 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Poland: Ministry of Health |
Study type | Interventional |
The purpose of this study is to assess:
- TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first
booster TBE vaccination with FSME-IMMUN 0.5ml given in Study 223, by means of ELISA
(IMMUNOZYM FSME IgG) and Neutralization test (NT),
- TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the
present study, by means of ELISA and NT,
- Safety of FSME-IMMUN 0.5ml after the second booster vaccination.
Status | Completed |
Enrollment | 314 |
Est. completion date | September 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects who participated in Study 223 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 first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223 - blood was drawn after their first booster vaccination in Study 223. Exclusion Criteria: Subjects will be excluded from participation in this study if they: - received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml - have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster 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 first booster 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). 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) - 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 - are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination) - have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223 - 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 - do not agree to keep a Subject Diary. - Subjects who meet the eligibility criteria, but have a febrile illness (body temperature >= 38.0°C, measured orally) at the scheduled time of vaccination, will not be vaccinated until their body temperature returns to normal. - Subjects who have been administered any vaccination within 2 weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed. - If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later time. - If a subject had a tick-bite within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed such that an interval of 4 weeks has passed since the tick-bite in order to avoid any interference with diagnostic assays in the event of a TBE infection. - If a subject has donated blood or plasma or has received a blood transfusion or immunoglobulins within 4 weeks of the scheduled booster vaccination, the vaccination shall be delayed until an interval of 4 weeks has passed. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Poland | Hospital in Debica - Zespol Opieki Zdrowotnej w Debicy | Debica | |
Poland | Szpital Jana Pawla II (The John Paul II Hospital) Oddzial Neuroinfekcji | Krakow |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seropositivity rate measured by Enzyme-Linked Immunosorbent Assay (ELISA) and/or Neutralization test (NT) 24, 34, 46 and 58 months after the first booster TBE vaccination in Study 223 and after the booster vaccination in this study | 24, 34, 46 and 58 months after the the first booster TBE vaccination in Study 223 and after the booster vaccination in this study (study ID 690701) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01031537 -
Vaccine Study for Tick-Borne Encephalitis Virus (TBEV)
|
Phase 2 | |
Completed |
NCT00460486 -
Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule
|
Phase 3 | |
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 |
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 |
NCT00161889 -
FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years
|
Phase 2 | |
Completed |
NCT00161850 -
FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 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 |