Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

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. Identifier: NCT00349141
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : October 9, 2015
Information provided by:
Nanotherapeutics, Inc.

Brief Summary:
The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next (higher) dose.

Condition or disease Intervention/treatment Phase
Influenza Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: A Phase I/II Dose Escalation Study of a Vero Cell-Derived, Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 45 Years
Study Start Date : June 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Male and femal subjects who

  • are 18 to 45 years of age, inclusive, on the day of screening;
  • have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
  • are clinically healthy, as determined by medical history and physical examination;
  • agree to keep a daily record of symptoms;
  • if female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Subjects who

  • are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);
  • suffer from a significant neurological, cardiac, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological or renal disorder;
  • are unable to lead an independent life as a result of either physical or mental handicap;
  • suffer from any kind of immunodeficiency;
  • suffer from a disease or are undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs;
  • have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré);
  • have a history of severe allergic reactions or anaphylaxis;
  • have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
  • have received a blood transfusion or immunoglobulins within 90 days of study entry;
  • have donated blood or plasma within 30 days of study entry;
  • have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;
  • have undergone systemic corticoid therapy within 30 days prior to study entry;
  • have a functional or surgical asplenia;
  • have a known or suspected problem with alcohol or drug abuse;
  • were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product;
  • are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator;
  • if female, are pregnant or lactating.

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 identifier (NCT number): NCT00349141

University Hospital, Department of Clinical Pharmacology, General Hospital Vienna
Vienna, Austria, 1090
National University Hospital
Singapore, Singapore, 119074
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Nanotherapeutics, Inc.
Principal Investigator: Baxter BioScience Investigator, MD Baxter Healthcare Corporation

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00349141     History of Changes
Other Study ID Numbers: 810501
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2007

Keywords provided by Nanotherapeutics, Inc.:
Pandemic influenza

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