Safety and Immunogenicity of One Dose of Inactivated Trivalent Flu Vaccine Administered to Non-elderly Adult and Elderly Subjects
NCT01151059 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138
Last updated 2012-03-28
Summary
The present study will evaluate the safety and immunogenicity in healthy people (non-elderly adult and elderly subjects) after one intramuscular (IM) dose of trivalent subunit inactivated flu vaccine.
Conditions
Interventions
- BIOLOGICAL
-
Trivalent subunit inactivated flu vaccine, Formulation 2010-2011
This phase II is performed as a multicenter study site in non-elderly adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22).
Sponsors & Collaborators
-
Novartis Vaccines
lead INDUSTRY
Principal Investigators
-
Novartis Vaccines · Novartis Vaccines
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2010-06-30
- Completion
- 2010-07-31
Countries
- Italy
Study Locations
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