Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00258830
First received: November 24, 2005
Last updated: January 16, 2014
Last verified: January 2014
  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 the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), 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.


Condition Intervention Phase
Influenza
Biological: Fluzone®: Influenza Virus Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Annual Study of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination [ Time Frame: Day 0 to 3 post-vaccination ] [ Designated as safety issue: Yes ]
  • Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
    GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation)


Other Outcome Measures:
  • Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination. [ Time Frame: 21 Days post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination.

  • Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination [ Time Frame: Day 21 post-vaccination ] [ Designated as safety issue: No ]
    Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination.


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
Experimental: Age 18 to 59 years
Participants aged 18 to 59 years at enrollment.
Biological: Fluzone®: Influenza Virus Vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®
Experimental: Age 60 years and older
Participants aged 60 years and older at enrollment.
Biological: Fluzone®: Influenza Virus Vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®

  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.
  • 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 posed a health risk to the subject if enrolled or interfered 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 interfered with the subject's ability to comply with trial procedures.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00258830     History of Changes
Other Study ID Numbers: GRC25
Study First Received: November 24, 2005
Results First Received: March 5, 2009
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014