Status:

COMPLETED

Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.

Lead Sponsor:

Solvay Biologicals

Conditions:

Influenza

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2008

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00665509

Start Date

June 1 2008

End Date

July 1 2008

Last Update

August 13 2008

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Site 1

Tessenderlo, Belgium

2

Site 2

Hamburg, Germany