Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 09/10 Season

Abbott 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 subjects in good health: 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.

Locations (2)

Site Reference ID/Investigator# 59243

Tessenderlo, Belgium

Site Reference ID/Investigator# 59244

Hamburg, Germany

Outcomes

Primary Outcomes

HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2008/2009 as defined by the CHMP guideline for influenza vaccines.

Time frame: 2 weeks

HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2008/2009 as defined by the CHMP guideline for influenza vaccines.

Time frame: 3 weeks