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

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).

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 59243, Tessenderlo, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trivalent influenza subunit vaccine Influvac

Biological

3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

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

Sponsors and collaborators

Lead sponsor

Abbott Biologicals

Industry

Collaborators

Quintiles, Inc.

Registry information

Official study title

Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2009/2010. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Apr 15, 2009
Registry last updated: Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed