Trials / Completed
CompletedNCT00503529
TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)
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)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 314 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) | Vaccination by intramuscular injection into the right or left upper arm (musculus deltoideus) |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2010-07-01
- Completion
- 2010-09-01
- First posted
- 2007-07-18
- Last updated
- 2015-05-21
Locations
2 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT00503529. Inclusion in this directory is not an endorsement.