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

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ClinicalTrials.gov Identifier: NCT00434733
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : April 24, 2008
Novartis Vaccines
Information provided by:

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

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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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Adverse event rate

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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

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Centrum Badań Farmakologii Klinicznej monipol
Kraków, Poland, 30-969
Sponsors and Collaborators
Novartis Vaccines
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Study Chair: Novartis Vaccines and Diagnostics GmbH & Co KG Novartis Novartis Vaccines and Diagnostics GmbH & Co KG., Germany
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ClinicalTrials.gov Identifier: NCT00434733    
Other Study ID Numbers: V87P4
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
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases