Trials / Completed
CompletedNCT00161824
Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
Single-blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,800 (planned)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 16 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) |
Timeline
- Start date
- 2001-10-01
- Completion
- 2002-01-01
- First posted
- 2005-09-13
- Last updated
- 2015-05-21
Locations
7 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT00161824. Inclusion in this directory is not an endorsement.