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Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00434733
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : April 24, 2008
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis

Study Description
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Brief Summary:
This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.

Condition or disease Intervention/treatment Phase
Influenza Biological: Pandemic influenza vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
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
Study Start Date : January 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Adverse event rate

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
  • Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
  • Surgery planned during the study period
  • Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
  • Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
  • History of (or current) drug or alcohol abuse
  • Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434733


Locations
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Poland
Centrum Badań Farmakologii Klinicznej monipol
Kraków, Poland, 30-969
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
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Study Chair: Novartis Vaccines and Diagnostics GmbH & Co KG Novartis Novartis Vaccines and Diagnostics GmbH & Co KG., Germany
More Information
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ClinicalTrials.gov Identifier: NCT00434733    
Other Study ID Numbers: V87P4
2006-005428-18
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: April 24, 2008
Last Verified: April 2008
Keywords provided by Novartis:
Influenza H5N1, pandemic
Additional relevant MeSH terms:
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Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases