Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

Completed · Phase 4

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00831987

Run by

Sanofi Pasteur, a Sanofi Company

People needed

120

Starts

2004-08-01

Expected to finish

2006-02-01

Last updated by the study team

2016-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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