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OpenTrials
Completed

NCT Number: NCT00311493

Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults

The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regensburg, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers of both sexes aged >18 who participated in another study on TBE vaccination

Exclusion criteria

  • Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Treatment and study plan

Tick-Borne Encephalitis vaccine

Biological

Primary outcomes

  1. Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.

Secondary outcomes

  1. Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study title

A Phase IV, Randomized, Open-Label, Multi-Center Study in Adults: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer) in Study V48P2E1, 5 Years After First Booster Immunization and Evaluation of Booster Kinetics in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer), 5 Years After First Booster Immunization

Important dates

Study start
2006
First posted
Apr 6, 2006
Registry last updated
Mar 13, 2007

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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