TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223) (NCT00503529) | Clinical Trial Compass
CompletedPhase 4
TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)
Poland314 participantsStarted 2007-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 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)