Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00664417

Purpose

Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.

Condition	Intervention	Phase
Influenza Orthomyxoviridae Infections	Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Physiological saline	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Safety and Immunogenicity of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine in Healthy Adults

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the safety after primary administration of A/H1N1 vaccine [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment:	375
Study Start Date:	April 2008
Study Completion Date:	August 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 1
Experimental: 2	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 2
Experimental: 3	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 3
Experimental: 4	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 4
Experimental: 5	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 5
Experimental: 6	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Formulation 6
Active Comparator: 7	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Comparator 1
Active Comparator: 8	Biological: Monovalent subvirion H5N1 influenza vaccine 0.5 mL, IM, 2 injections, Comparator 2
Placebo Comparator: 9	Biological: Physiological saline 0.5 mL, IM, 2 injections

Detailed Description:

This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults. Immunogenicity and safety will be evaluated after each injection.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

Healthy adult aged 18 to 40 years on the day of inclusion.
Provides signed informed consent prior to study procedures.
Able to attend all scheduled visits and comply with all trial procedures.
For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.

Exclusion Criteria :

Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances
For a woman of child-bearing potential, known pregnancy or positive serum/urine pregnancy test
Breast feeding woman
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the (first) trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, oral, parenteral, or inhaled steroids
Has an acute or chronic medical illness or any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or would interfere with the evaluation of responses or render the subject unable to meet the requirements of the protocol
Known or suspected current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
History of receipt of blood or immunoglobulin or other blood-derived products within the 3 months prior to enrollment in this study that might interfere with the assessment of immune response
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
Planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination
Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity
Personal or family history of Guillain-Barré Syndrome
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
Active neoplastic disease or a history of any hematologic malignancy
Previous participation in a pandemic flu trial
History of H5N1 infection or exposure to presumed/confirmed H5N1 human/animal cases
Known seizure/epilepsy history and/or taking anti-seizure medication
Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664417

Locations

United States, California

San Diego, California, United States, 92103
United States, Florida

South Miami, Florida, United States, 33143
United States, Missouri

Springfield, Missouri, United States, 65802
United States, Ohio

Cincinnati, Ohio, United States, 45219

Cincinnati, Ohio, United States, 45227
United States, Tennessee

Knoxville, Tennessee, United States, 37920

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Monitor, Sanofi Pasteur, Inc.
ClinicalTrials.gov Identifier:	NCT00664417 History of Changes
Other Study ID Numbers:	FUF04
Study First Received:	April 22, 2008
Last Updated:	April 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Influenza
A/H5N1
Orthomyxoviridae Infections
Influenza Pandemics

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 February 09, 2012