Trials / Completed
CompletedNCT00840801
Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
SINGLE-BLIND, RANDOMIZED, PHASE III B STUDY IN CHILDREN AGED 1 - 11 YEARS TO INVESTIGATE THE IMMUNOGENICITY, SAFETY AND INTERCHANGEABILITY OF TWO TICK-BORNE ENCEPHALITIS (TBE) VACCINES ADMINISTERED ACCORDING TO A CONVENTIONAL SCHEDULE
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 302 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 1 Year – 11 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) | Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360 |
| BIOLOGICAL | Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) | Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360. |
Timeline
- Start date
- 2009-02-06
- Primary completion
- 2010-05-20
- Completion
- 2010-05-20
- First posted
- 2009-02-10
- Last updated
- 2024-01-19
- Results posted
- 2024-01-19
Locations
8 sites across 2 countries: Austria, Czechia
Source: ClinicalTrials.gov record NCT00840801. Inclusion in this directory is not an endorsement.