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

Solvay Biologicals120 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Influenza

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2008/2009

Time frame: 2 and 3 weeks

Secondary Outcomes

HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)