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OpenTrials
Completed

NCT Number: NCT00311441

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

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

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Key information

Conditions

Encephalitis, Tick-borne Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Tick-Borne Diseases Vector Borne Diseases Virus Diseases

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weilheim, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tick-Borne Encephalitis vaccine

Biological

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study 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.

Important dates

Study start
2005
First posted
Apr 6, 2006
Registry last updated
Mar 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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