Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00895544
First received: May 7, 2009
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule.


Condition Intervention Phase
Influenza
Avian Influenza
Biological: Influenza vaccine (whole virion, Vero cell derived)
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 1/2 Study to Assess the Immunogenicity and Safety of a Single Prime-Boost Vaccination Schedule With a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 59 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 booster vaccination defined as titer measured by microneutralization test >= 1:20. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with antibody response associated with protection 21, 42, 180 and 360 days after the priming vaccination and 21 days after the booster vaccination [ Time Frame: at the timepoints stated above ] [ Designated as safety issue: No ]

Enrollment: 231
Study Start Date: May 2009
Study Completion Date: June 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose B of whole virion, Vero cell-derived influenza vaccine (Indonesia strain)
Biological: Influenza vaccine (whole virion, Vero cell derived)
Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose B (Indonesia strain) for booster vaccination (Day 360)
Experimental: 2
Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Indonesia strain)
Biological: Influenza vaccine (whole virion, Vero cell derived)
Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose A (Indonesia strain) for booster vaccination (Day 360)

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

  • are 18 to 59 years of age, inclusive, on the day of screening
  • have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry
  • are generally 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 and follow its procedures
  • agree to keep a daily record of symptoms for the duration of the study
  • if female of childbearing potential: have a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

  • have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
  • are at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
  • currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
  • have any inherited or acquired immunodeficiency
  • have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment within 30 days prior to study entry 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 severe allergic reactions or anaphylaxis
  • have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating
  • have received any blood products or immunoglobulins within 90 days prior to study entry
  • have donated blood or plasma within 30 days prior to study entry
  • have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
  • have a functional or surgical asplenia
  • have a known or suspected problem with alcohol or drug abuse
  • were administered an investigational drug within 6 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 one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
  • if female: are pregnant or lactating
  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: NCT00895544

Locations
Austria
General Hospital of Vienna (AKH Wien), Dept. of Clinical Pharmacology
Vienna, Austria, 1090
Finland
Espoon rokotetutkumusklinikka
Espoo, Finland, 02100
Etelä - Helsingin rokotetutkimusklinikka
Helsinki, Finland, 00100
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Gerald Aichinger, MD Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Gerald Aichinger, MD; Study Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00895544     History of Changes
Other Study ID Numbers: 810802
Study First Received: May 7, 2009
Last Updated: July 21, 2011
Health Authority: Austria: Federal Ministry for Health Family and Youth
Finland: Finnish Medicines Agency

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

ClinicalTrials.gov processed this record on September 14, 2014