Safety & Long-term Evaluation (up to 5 Years) of First Booster

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

Tick Born Encephalitis Clinical Trial

Official 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

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00387634
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 4
Start date	September 2006
Completion date	October 2011

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms