NCT00460486

Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (planned)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Encephalitis, Tick-Borne

Interventions

Type	Name	Description
BIOLOGICAL	Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-11-01
• First posted: 2007-04-16
• Last updated: 2023-04-19

Locations

4 sites across 1 country: Poland