Trials / Completed
CompletedNCT00161863
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 1 Year – 15 Years
- Healthy volunteers
- —
Summary
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | FSME-IMMUN NEW 0.25 ml |
Timeline
- Start date
- 2002-09-01
- Completion
- 2003-01-01
- First posted
- 2005-09-13
- Last updated
- 2015-05-21
Locations
8 sites across 3 countries: Austria, Germany, Poland
Source: ClinicalTrials.gov record NCT00161863. Inclusion in this directory is not an endorsement.