Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)

• Registration Number: NCT00389532
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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: 2006-10
• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Primary Completion: 2008-04
• Study Completion: 2008-09
• Results First Submitted: 2009-02-24
• Results First Submitted QC: 2009-03-27
• 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: 116

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 Fluzone® vaccination at Visit 1.
• 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 abuse of alcohol or drug addiction 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)	aged 19 to 59 years
2	Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)	aged ≥ 60 years

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination	0-3 days post-vaccination	Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination	21 days post-vaccination	GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.