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Influenza Biological: Pandemic influenza vaccine Phase III

MedlinePlus related topics: Bird Flu Flu
Drug Information available for: Fluvirin Influenza Vaccines
U.S. FDA Resources
Study Type: Interventional

Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment,
Safety Study

Official Title: A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to
Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-
H5N1 Influenza Vaccine in Adult and Elderly Subjects

Further study details as provided by Novartis:

Primary Outcome Measures:

• Adverse event rate

http://clinicaltrials.gov/ct2/show/NCT00434733

Secondary Outcome Measures:
• Seroconversion and seroprotection after two doses of H5N1 vaccine

Estimated Enrollment: 4400

Study Start Date: January 2007

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:
• Healthy Subjects 18 years of age who signed the informed consent

Exclusion Criteria:

• Receipt of another investigational agent within 4 weeks
• Receipt of influenza vaccination for current season 2006/2007.

• any acute disease or infection, history of neurological symptoms or signs, known or
suspected impairment of immune function, any serious disease, bleeding diathesis
• fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)