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OpenTrials
Completed

NCT Number: NCT00387634

Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults

evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster

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Key information

Conditions

Tick Born Encephalitis

Age range

15 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hradec Králové, 500 03, Czechia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy subjects who have completed study V48P7

Exclusion criteria

  • acute illness at day of immunization
  • general decrease in resistance
  • progressive neurological disorders
  • history of febrile or afebrile convulsions
  • major congenital defects
  • serious chronic illness
  • hypersensitivity to study vaccine
  • treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates

Treatment and study plan

TBE vaccine for adults

Biological

Serology blood draw.

Primary outcomes

  1. immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA

    Time frame: On day 21, year 1, year 2, year 3, year 4, year 5

Secondary outcomes

  1. safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting

    Time frame: Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 13, 2006
Registry last updated
Nov 2, 2012

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.