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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00349141
First received: July 5, 2006
Last updated: October 8, 2007
Last verified: October 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 270
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349141

Locations
Austria
University Hospital, Department of Clinical Pharmacology, General Hospital Vienna
Vienna, Austria, 1090
Singapore
National University Hospital
Singapore, Singapore, 119074
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator, MD Baxter Healthcare Corporation
  More Information

No publications provided by Baxter Healthcare Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00349141     History of Changes
Other Study ID Numbers: 810501
Study First Received: July 5, 2006
Last Updated: October 8, 2007
Health Authority: Austria: Federal Ministry for Health and Women (AGES, PharmMed)
Singapore: Health Sciences Authority

Keywords provided by Baxter Healthcare Corporation:
Pandemic influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014