Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00258830

Purpose

To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged >=60 years.

To describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged >= 60 years.

To submit remaining available sera to CBER for further analysis by FDA, CDC and WHO to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Condition	Intervention	Phase
Influenza	Biological: Influenza Virus Vaccine	Phase IV

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the safety of Fluzone vaccine [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	September 2005
Study Completion Date:	March 2007
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Influenza Virus Vaccine 0.5 mL, Intramuscular

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 on the day of inclusion.
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.
For a woman, inability to bear a child or negative serum/urine pregnancy test.

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 >=99.5°F oral) in the 72 hours preceding enrollment in the trial.
Clinically significant findings in vital signs (including temperature >=99.5°F oral) on review of systems.
Self-reported history of severe adverse event to any influenza vaccine.
Laboratory-confirmed influenza infection or 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.
Vaccination planned in the 4 weeks following any trial vaccination.
Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258830

Locations

United States, Virginia

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur Inc. ( Medical Director )
Study ID Numbers:	GRC25
Study First Received:	November 24, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00258830
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Influenza vaccine

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009