Skip to main content
OpenTrials
Completed

NCT Number: NCT01106482

An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tick Borne Encephalitis (TBE) Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Tick-Borne 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

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Winkelhoferstr. 3, Ehingen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent

Exclusion criteria

  • Subjects who did not receive complete schedule of primary vaccination in the parent study
  • Subjects enrolled in other investigational studies at the same time and within the last three months
  • Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Treatment and study plan

Serology blood draw

Other

Blood draw only, no vaccine

Primary outcomes

  1. Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination

    Time frame: 3 years after vaccination

  2. Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination

    Time frame: 4 years after vaccination

  3. Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination

    Time frame: 5 years after vaccination

Secondary outcomes

  1. Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination

    Time frame: 3 years after vaccination

  2. Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination

    Time frame: 4 years after vaccination

  3. Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination

    Time frame: 5 years after vaccination

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 20, 2010
Registry last updated
Dec 8, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.