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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00311441
• Collaborator: Novartis Vaccines (Industry)
• Enrollment: 300
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Encephalitis, Tick-Borne	Biological: Tick-Borne Encephalitis vaccine	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Prevention
• Official Title: A Phase IV, Randomized, Controlled, Single-Blind, Multi-Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules.
• Study Start Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Weilheim		Germany

Sponsors and Collaborators

• Novartis
• Novartis Vaccines

Investigators

• Study Director: Drug Information Services, Novartis Vaccines & Diagnostics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00311441
• Other Study ID Numbers: M48P3; 911
• First Posted: Apr 6, 2006
• Last Update Posted: Mar 17, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: TBE, children, vaccine
• Additional relevant MeSH terms: Encephalitis, Tick-Borne; Encephalitis

Study Results

No Results Posted as of Mar 17, 2008