Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
NCT00310648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2006-09-14
Summary
Clinical Trial in Two parts:
Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects.
Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects.
Conditions
Interventions
- BIOLOGICAL
Sponsors & Collaborators
-
Novartis Vaccines
collaborator INDUSTRY -
Chiron s.r.l. Beijing Representative Office
collaborator UNKNOWN - lead INDUSTRY
Principal Investigators
-
Novartis Vaccines - Drug Information Services · Novartis Vaccines & Diagnostics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-01-31
Countries
- China
Study Locations
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