Status:
COMPLETED
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Eligibility Criteria
Inclusion
- Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
- Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
- For additional entry criteria, please refer to protocol.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
2719 Patients enrolled
Trial Details
Trial ID
NCT00973349
Start Date
September 1 2009
End Date
December 1 2010
Last Update
December 7 2015
Active Locations (21)
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1
Miami Research Associates
Miami, Florida, United States, 33143
2
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
3
Meridien Clinical Research
Omaha, Nebraska, United States, 68134
4
Regional Clinical Research
Endwell, New York, United States, 13760