Trial to Describe the Safety and Immunogenicity of Fluzone®

Influenza Clinical Trial

Official title:

Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524940
• Other study ID #: GRC37
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2007
• Last updated: April 12, 2016
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Inactivated, Split-Virion Influenza Virus
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.	Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.	0-3 days post-vaccination and entire study duration	Yes
Primary	Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.	GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.	21 days post-vaccination	No

External Links

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