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

August 24, 2011 updated by: Abbott Biologicals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Tessenderlo, Belgium, 3890
        • Site Reference ID/Investigator# 59243
  • Germany
      • Hamburg, Germany, 22769
        • Site Reference ID/Investigator# 59244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: Trivalent influenza subunit vaccine Influvac
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Biologicals

Collaborators

Quintiles, Inc.

Investigators

  • Study Director: Hanka de Voogd, MD, Abbott Healthcare Products B.V

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 14, 2009

First Submitted That Met QC Criteria

April 14, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2011

Last Update Submitted That Met QC Criteria

August 24, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S201.3.128
  • 2009-010900-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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