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Trial record 1 of 1 for:    NCT00530660
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Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)

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: NCT00530660
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : October 9, 2015
Information provided by:
Ology Bioservices

Brief Summary:
The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A data safety monitoring board will review the safety data after the booster vaccination. The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.

Condition or disease Intervention/treatment Phase
Influenza Biological: H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label Phase II Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Heterologous Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Young Adult Population (Follow Up to Study 810501)
Study Start Date : September 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Biological: H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted
    All subjects who have completed the Day 42 visit at the Austrian study site in Study 810501 will be invited to receive a booster vaccination, 12 to 17 months after the first vaccination with the A/Vietnam/1203/2004 influenza vaccine administered in Study 810501, with a heterologous whole virion, Vero cell-derived influenza vaccine containing 7.5 mg A/H5N1/Indonesia/05/2005 hemagglutinin (HA) antigen in a non-adjuvanted formulation.

Primary Outcome Measures :
  1. Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination (HI antibody titer >= 1:40 or MN titer >= 1:20) [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Subjects who participated in Study 810501 will be eligible for participation in the study if they:

  • Completed the Day 42 visit in study 810501
  • 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
  • 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 at study entry and agree to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

  • Have a history of vaccination with an H5N1 influenza virus since the second vaccination in study 810501
  • Have had an allergic reaction to one of the components of the vaccine since the second vaccination in Study 810501
  • Have been diagnosed with a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, renal or metabolic disorder since the second vaccination in Study 810501
  • Are unable to lead an independent life as a result of either physical or mental handicap
  • Suffer from any kind of immunodeficiency since the second vaccination in Study 810501
  • Suffer from a disease or were undergoing a treatment within 30 days prior to the scheduled booster vaccination or are currently 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 had severe allergic reactions or anaphylaxis since the second vaccination in Study 810501
  • Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
  • 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): NCT00530660

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University Hospital, Department of Clinical Pharmacology, General Hospital Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Ology Bioservices
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Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Simone Deutschel, Clinical Project Manager, Baxter Healthcare Corporation Identifier: NCT00530660    
Other Study ID Numbers: 810703
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: December 2008
Keywords provided by Ology Bioservices:
Pandemic influenza
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs