Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01430819
First received: September 7, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

The aim of the study is to evaluate the safety and immunogenicity of the 2011-2012 formulation of Fluzone and Fluzone High-Dose vaccines in participants aged 65 years and older.

Objectives:

  • To describe the safety of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.
  • To describe the immunogenicity of Fluzone vaccine and Fluzone High-Dose vaccine among adults ≥ 65 years of age.

Condition Intervention Phase
Influenza
Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 to up to Day 28 post-vaccination ] [ Designated as safety issue: No ]

    Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

    Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling > 100 mm.



Other Outcome Measures:
  • Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine. [ Time Frame: Day 21 post-vaccination ] [ Designated as safety issue: No ]
    Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.

  • Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine [ Time Frame: Day 21 post-vaccination ] [ Designated as safety issue: No ]

    Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.

    Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40; or a pre-vaccination titer ≥ 1:10 and a four-fold increase in post-vaccination titer.


  • Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine. [ Time Frame: Day 21 post-vaccination ] [ Designated as safety issue: No ]

    Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.

    Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios.



Enrollment: 300
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluzone® Vaccine Group
Participants will receive the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
0.5 mL, Intramuscular
Other Name: Fluzone® 2011-2012 Formulation
Active Comparator: Fluzone® High-Dose Vaccine Group
Participants will receive the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
0.5 mL, Intramuscular
Other Name: Fluzone® High-Dose 2011-2012 Formulation

Detailed Description:

Historically, the annual safety and immunogenicity study of Fluzone vaccine has been conducted in the US in support of licenses held by sanofi pasteur in various countries.

Participants will be randomized to receive a dose of either Fluzone® or Fluzone® High-Dose vaccine and will be followed up for safety and immunogenicity. The duration of participation in the trial will be approximately 1 month.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is ≥ 65 years of age on the day of inclusion.
  • Informed consent form (ICF) has been signed and dated.
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • History of serious adverse reaction to any influenza vaccine.
  • Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the 2nd visit.
  • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study.
  • Influenza vaccination in the 6 months preceding enrollment in the study.
  • Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Investigator's Brochure and/or the package insert) .
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
  • Thrombocytopenia, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator.
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for IM vaccination, at the discretion of the Investigator.
  • 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.
  • Personal history of Guillain-Barré syndrome.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the subject.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
  • Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
  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: NCT01430819

Locations
United States, Colorado
Colorado Springs, Colorado, United States, 80920
United States, Iowa
Council Buffs, Iowa, United States, 51503
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Missouri
Springfield, Missouri, United States, 65804
United States, Pennsylvania
Bensalem, Pennsylvania, United States, 19020
United States, Texas
Austin, Texas, United States, 78705
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: NCT01430819     History of Changes
Other Study ID Numbers: GRC48, U 1111-1120-1287
Study First Received: September 7, 2011
Results First Received: March 18, 2013
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Influenza Virus Vaccine
Fluzone® 2011-2012 Formulation
Fluzone® High-Dose 2011-2012 Formulation
Trivalent Inactivated Influenza Vaccine

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

ClinicalTrials.gov processed this record on September 30, 2014