Overview

Yearly Licence Tolerability and Immunogenicity Study of Fluval AB Seasonal Influenza Vaccine to be Used in the 2012/2013 Vaccination Season

Status:
Completed

Trial end date:
2012-09-01

Target enrollment:

Participant gender:

Summary

This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection, as measured by haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.

Phase:

Phase 4

Details

Lead Sponsor:

Fluart Innovative Vaccine Ltd, Hungary
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.

Treatments:

Vaccines