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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier:
NCT00881842
First received: April 14, 2009
Last updated: August 24, 2011
Last verified: August 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Influenza
 Biological: Trivalent influenza subunit vaccine Influvac
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Trivalent influenza subunit vaccine Influvac
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881842

Locations
Belgium
Site Reference ID/Investigator# 59243
Tessenderlo, Belgium, 3890
Germany
Site Reference ID/Investigator# 59244
Hamburg, Germany, 22769
Sponsors and Collaborators
Abbott Biologicals
Quintiles
Investigators
Study Director: Hanka de Voogd, MD Abbott Healthcare Products B.V
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Biologicals )
ClinicalTrials.gov Identifier: NCT00881842     History of Changes
Other Study ID Numbers: S201.3.128, 2009-010900-27
Study First Received: April 14, 2009
Last Updated: August 24, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Paul-Ehrlich-Institut

Keywords provided by Abbott:
Influenza
Vaccine
CHMP criteria

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013