Status:
COMPLETED
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
29-60 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA...
Eligibility Criteria
Inclusion
- Healthy Japanese adults aged 20 to 60 years
Exclusion
- History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
- Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
- Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
- History of progressive or severe neurological disorders
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00996138
Start Date
September 1 2009
End Date
November 1 2009
Last Update
December 1 2016
Active Locations (1)
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1
Osaka pref.
Kagoshima Pref., Japan