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Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

NCT00840801 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2024-01-19

Study results available
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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

  • Encephalitis, Tick-Borne

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

  • Baxter Bioscience Investigator · Baxter BioScience

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE

Eligibility

Min Age
1 Year
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-06
Primary Completion
2010-05-20
Completion
2010-05-20

Countries

  • Austria
  • Czechia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00840801 on ClinicalTrials.gov