Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children
NCT01776554 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 662
Last updated 2019-01-16
Summary
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.
Conditions
- Pandemic H5N1 Influenza
Interventions
- BIOLOGICAL
-
Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
Sponsors & Collaborators
-
Department of Health and Human Services
collaborator FED -
Novartis Vaccines
lead INDUSTRY
Principal Investigators
-
Novartis vaccines and Diagnostics · Novartis Vaccines
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2013-06-30
- Completion
- 2014-06-30
Countries
- United States
- Thailand
Study Locations
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