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Annual Study to Investigate Influenza Vaccine Due to New Virus Strains for the 2007/2008 Influenza Season in Europe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00479921
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : January 30, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: Trivalent influenza subunit vaccine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Reactogenicity of Trivalent Influenza Subunit Vaccine Influvac® for the Season 2007/2008. An Open, Baseline-Controlled Multi-Center Study in Two Groups of Healthy Subjects: Adults and Elderly
Study Start Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2007/2008

Secondary Outcome Measures :
  1. HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed and dated informed consent.
  • Healthy and aged >= 18 and <= 60 years or >= 61 years of age.
  • Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire.

Exclusion Criteria:

  • Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
  • Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
  • Having experienced a serious systemic and/or local reaction after previous influenza vaccination.
  • Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
  • Having received vaccination against influenza within the previous six months before Visit 1.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479921


Locations
Belgium
Site 1
Tessenderlo, Belgium
Germany
Site 2
Hamburg, Germany
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
More Information

ClinicalTrials.gov Identifier: NCT00479921     History of Changes
Other Study ID Numbers: S201.3.126
2007-000875-40
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by Solvay Pharmaceuticals:
Influenza
Vaccine
CHMP criteria

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs