Trial to Describe the Safety and Immunogenicity of Fluzone®

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Inactivated, Split-Virion Influenza Virus

• Registration Number: NCT00524940
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation.

Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation.

Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2007-09
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Study Completion: 2007-12
• Results First Submitted: 2009-02-24
• Results First Submitted QC: 2009-02-24
• Results First Posted: 2009-03-30
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 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 2.
• Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.
• Immunocompromising 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 6 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 potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial.
• Current alcohol or drug use that may interfere with the subject's ability to comply with trial procedures.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
• Prior personal history of Guillain-Barré syndrome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Inactivated, Split-Virion Influenza Virus	-

Primary Outcome Measures

Name	Time	Method
Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.	0-3 days post-vaccination and entire study duration	Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.	21 days post-vaccination	GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.