Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

Novartis300 enrolled

Overview

The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

300

Conditions

Encephalitis, Tick-Borne

Interventions

Tick-Borne Encephalitis vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 1 YearMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female children, 1 to 10 years of age. Exclusion Criteria: * Subjects with documented evidence of TBE * Subjects, who have been previously vaccinated against TBE

Locations (1)

Unnamed facility

Weilheim, Germany

Outcomes

Primary Outcomes

Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.

Secondary Outcomes

Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever

Data from ClinicalTrials.gov

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