Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.

Solvay

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Trivalent influenza subunit vaccine Influvac

Study type

Interventional

Funder types

Industry

Identifiers

NCT00665509

S201.3.127

2008-001038-28

Details and patient eligibility

About

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Willing and able to give informed consent and able to adhere to all protocol required study procedures.
Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion criteria

Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period.
A history of Guillain-Barré syndrome or active neurological disease.