A/H1N1 Immunogenicity and Safety in Adults
NCT00959465 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 408
Last updated 2015-10-09
Summary
The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.
Conditions
- Influenza
- Pandemic Influenza
Interventions
- BIOLOGICAL
-
H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Two injections at a 21-day interval (Days 1 and 22)
Sponsors & Collaborators
-
Alachua Government Services, Inc.
lead INDUSTRY
Principal Investigators
-
Gerald Aichinger, MD · Baxter Healthcare Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2009-11-30
- Completion
- 2010-04-30
Countries
- Austria
- Germany
Study Locations
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