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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

September 7, 2011
May 16, 2013
September 2011
February 2012   (final data collection date for primary outcome measure)
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.

Information on safety in terms of solicited injection site and systemic events and unsolicited adverse events following vaccination with influenza virus vaccines. [ Time Frame: Day 0 up to 21 days post-vaccination ] [ Designated as safety issue: No ]
Solicited injection site: Pain, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.
Complete list of historical versions of study NCT01430819 on ClinicalTrials.gov Archive Site
Not Provided
Information on the immune response to each of the influenza virus strains at 21 days post vaccination. [ Time Frame: Day 0 and Day 21 post-vaccination ] [ Designated as safety issue: No ]
Immunogenicity will be evaluated prior to vaccination and at 21 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) will be calculated.
  • 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.

Not Provided
 
Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults
Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
    0.5 mL, Intramuscular
    Other Name: Fluzone® 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
  • Experimental: Fluzone® Vaccine Group
    Participants will receive the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
    Intervention: Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
  • Active Comparator: Fluzone® High-Dose Vaccine Group
    Participants will receive the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
    Intervention: Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01430819
GRC48, U 1111-1120-1287
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP