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

Novartis

Status and phase: Completed; Phase 4

Conditions: Encephalitis, Tick-Borne

Treatments: Biological: Tick-Borne Encephalitis vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311441

M48P3

911

Details and patient eligibility

About

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

Sex: All

Ages: 1 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind