Safety and Immunogenicity of the WHO Formulation of the 2004-2005 Fluzone® Vaccine - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00831987

Purpose

To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged >= 60 years.

To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged >= 60 years.

Condition	Intervention	Phase
Influenza	Biological: Influenza virus vaccine 2004-2005 formulation	Phase IV

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Immunogenicity: To provide information concerning the immunogenicity (or immune response) of Fluzone after primary vaccination. [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
Safety: To provide information concerning the safety after primary administration of Fluzone [ Time Frame: 4 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	August 2004
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fluzone Vaccine Group	Biological: Influenza virus vaccine 2004-2005 formulation 0.5 mL, Intramuscular

Detailed Description:

The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period.

Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

Participant aged 18 years or older.
Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
Participant is in reasonably good health as assessed by the investigator.
Participant willing and able to meet protocol requirements.
Participant willing and able to give informed consent.

Exclusion Criteria :

Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial.
Clinically significant findings in vital signs (including temperature >100.4°F) on review of systems.
Self-reported history of severe adverse event to any influenza vaccine.
Vaccination against influenza in the 6 months preceding enrollment in the study.
Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
Immunogenicity or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 3 months.
Receipt of blood or blood products within the 3 months preceding enrollment in the study.
Diabetes mellitus requiring pharmacological control.
Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine.
Person deprived of freedom by an administrative or court order (having legal or medical guardian).
For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831987

Locations

United States, Virginia

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers:	GRC20
Study First Received:	January 28, 2009
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00831987 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Influenza

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 06, 2009