Status:
COMPLETED
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season
Lead Sponsor:
Abbott Biologicals
Collaborating Sponsors:
Quintiles, Inc.
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
- 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.
- Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection 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
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01146015
Start Date
June 1 2010
End Date
July 1 2010
Last Update
August 26 2011
Active Locations (2)
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1
Site Reference ID/Investigator# 44974
Tessenderlo, Belgium, 3890
2
Site Reference ID/Investigator# 44975
Hamburg, Germany, 22769