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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00517517
First received: August 16, 2007
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review the safety data after the first and second vaccination.


Condition Intervention Phase
Influenza
Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-Label Phase I/II Study to Assess the Safety and Immunogenicity of Two Doses of a Vero Cell Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Volunteers Aged 21 to 45 Years

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20 [ Time Frame: 21 days after the second vaccination (= Day 42 in the study) ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: July 2007
Study Completion Date: February 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 7.5 µg of H5N1 HA antigen per 0.5 mL in a non-adjuvanted formulation
Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation
Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.
Experimental: 2
Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 3.75 µg of H5N1 HA antigen per 0.25 mL in a non-adjuvanted formulation
Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation
Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are 21 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 the Investigator's clinical judgment through collection of medical history and performance of a physical examination
  • Are physically and mentally capable of participating in the study
  • Agree to keep a daily record of symptoms for the duration of the study
  • If female and capable of bearing children, have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

  • Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza virus
  • Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
  • Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
  • Suffer from any inherited or acquired immunodeficiency
  • Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)
  • 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 syndrome)
  • 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 or site conducting the study
  • If female: are pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517517

Locations
Hong Kong
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, Hong Kong
Singapore
National University Hospital
Singapore, Singapore, 119074
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter Bio Science Investigator Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00517517     History of Changes
Other Study ID Numbers: 810701
Study First Received: August 16, 2007
Last Updated: September 23, 2011
Health Authority: Singapore: Health Sciences Authority
Hong Kong: Department of Health

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
Hemagglutinins
Agglutinins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014