Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501) - Full Text View

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00530660

Purpose

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	Intervention	Phase
Influenza	Biological: H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted	Phase II

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	141
Study Start Date:	September 2007
Study Completion Date:	October 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years to 46 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530660

Locations

Austria
University Hospital, Department of Clinical Pharmacology, General Hospital Vienna
Vienna, Austria, 1090

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Principal Investigator:

Baxter BioScience Investigator

Baxter Healthcare Corporation

More Information

Responsible Party:	Baxter Healthcare Corporation ( Simone Deutschel, Clinical Project Manager )
Study ID Numbers:	810703
Study First Received:	September 14, 2007
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00530660
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Baxter Healthcare Corporation:

Pandemic influenza

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human

Influenza in Birds
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009