Status:
COMPLETED
Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination
Lead Sponsor:
Abbott Biologicals
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Influenza
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged \>= 18 and \<= 64 years, plus revaccination
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 \<= 64 years.
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
- Exclusion Criteria
- Known to be allergic to constituents 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 or lab confirmed influenza within the previous six months before study vaccination.
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
1270 Patients enrolled
Trial Details
Trial ID
NCT00889889
Start Date
May 1 2009
End Date
January 1 2011
Last Update
October 25 2013
Active Locations (15)
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1
Site Reference ID/Investigator# 45690
Jacksonville, Florida, United States, 32216
2
Site Reference ID/Investigator# 45687
Pembroke Pines, Florida, United States, 33024
3
Site Reference ID/Investigator# 45697
South Miami, Florida, United States, 33143
4
Site Reference ID/Investigator# 45691
Lenexa, Kansas, United States, 66219