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

This study has been completed.
Novartis Vaccines
Information provided by:
Novartis Identifier:
First received: February 12, 2007
Last updated: April 23, 2008
Last verified: April 2008
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 Intervention Phase
Biological: Pandemic influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Adverse event rate

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

Estimated Enrollment: 4400
Study Start Date: January 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00434733

Centrum Badań Farmakologii Klinicznej monipol
Kraków, Poland, 30-969
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines and Diagnostics GmbH & Co KG Novartis Novartis Vaccines and Diagnostics GmbH & Co KG., Germany
  More Information Identifier: NCT00434733     History of Changes
Other Study ID Numbers: V87P4
Study First Received: February 12, 2007
Last Updated: April 23, 2008

Keywords provided by Novartis:
Influenza H5N1, pandemic

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017