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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.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00434733
First received: February 12, 2007
Last updated: April 23, 2008
Last verified: April 2008
  Purpose
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
Influenza
Biological: Pandemic influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434733

Locations
Poland
Centrum Badań Farmakologii Klinicznej monipol
Kraków, Poland, 30-969
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines and Diagnostics GmbH & Co KG Novartis Novartis Vaccines and Diagnostics GmbH & Co KG., Germany
  More Information

ClinicalTrials.gov Identifier: NCT00434733     History of Changes
Other Study ID Numbers: V87P4  2006-005428-18 
Study First Received: February 12, 2007
Last Updated: April 23, 2008
Health Authority: Poland: Central Register of Clinical Trials (CEBK)

Keywords provided by Novartis:
Influenza H5N1, pandemic

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016