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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

April 14, 2009
August 24, 2011
June 2009
July 2009   (final data collection date for primary outcome measure)
  • 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 ]
HI titers and its derived parameters after 2 and 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: 2 and 3 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00881842 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 09/10 Season
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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: Trivalent influenza subunit vaccine Influvac
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
Experimental: 1
Intervention: Biological: Trivalent influenza subunit vaccine Influvac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany
 
NCT00881842
S201.3.128, 2009-010900-27
No
Abbott ( Abbott Biologicals )
Abbott Biologicals
Quintiles
Study Director: Hanka de Voogd, MD Abbott Healthcare Products B.V
Abbott
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP