Status:
COMPLETED
Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
Lead Sponsor:
Abbott Biologicals
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses an...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Female or male subjects \>= 18 years of age (adults \>= 18 to \< =60 years of age or elderly \>= 61 years of age).
- Willing and able to give informed consent before any protocol procedures are performed.
- Able to adhere to visit schedules and all protocol required study procedures.
- Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).
- Exclusion Criteria
- Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
- Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
- A serious adverse reaction after a previous (influenza) vaccination.
- A history of Guillain-Barré syndrome.
- Known to be allergic to constituents of the study vaccines.
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
3138 Patients enrolled
Trial Details
Trial ID
NCT00999206
Start Date
January 1 2010
End Date
August 1 2010
Last Update
August 26 2011
Active Locations (19)
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1
Site Reference ID/Investigator# 44652
Adelaide, Australia, 5000
2
Site Reference ID/Investigator# 44662
Auchenflower, Australia, 4066
3
Site Reference ID/Investigator# 44651
Blacktown, Australia, 2148
4
Site Reference ID/Investigator# 44659
Blacktown, Australia, 2148