Status:
COMPLETED
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Lead Sponsor:
Novartis Vaccines
Conditions:
Prophylaxis: Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tole...
Eligibility Criteria
Inclusion
- Males or females 18 through 49 years of age.
- Subjects having provided informed consent.
- Individuals in good health
Exclusion
- Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
- Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
1561 Patients enrolled
Trial Details
Trial ID
NCT02256488
Start Date
September 1 2014
End Date
December 1 2014
Last Update
June 11 2019
Active Locations (24)
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1
Anaheim Clincial Trials
Anaheim, California, United States
2
Northern California Clinical Research Center
Redding, California, United States
3
Southern California CRC
San Diego, California, United States
4
Broward Research Group
Hollywood, Florida, United States