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Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults

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ClinicalTrials.gov Identifier: NCT01946438
Recruitment Status : Completed
First Posted : September 19, 2013
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE September 16, 2013
First Posted Date  ICMJE September 19, 2013
Results First Submitted Date  ICMJE September 17, 2014
Results First Posted Date  ICMJE September 25, 2014
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE September 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2014)
Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine. [ Time Frame: Day 0 up to Day 21 post-vaccination ]
Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Fluzone® influenza virus vaccines [ Time Frame: Day 0 up to 21 Days post vaccination ]
Solicited injection site reactions: Pain, Redness, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Unsolicited adverse events including serious adverse events will also be collected.
Change History Complete list of historical versions of study NCT01946438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2014)
  • Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 21 after vaccination ]
    Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.
  • Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 21 after vaccination ]
    Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution).
  • Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 21 after vaccination ]
    Influenza virus antibodies were measured using an 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 ≥ 4-fold increase in titer after vaccination.
  • Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine [ Time Frame: Day 21 after vaccination ]
    Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
  • Geometric mean titers of antibodies to vaccine antigens following vaccination with Fluzone® Quadrivalent, or Fluzone Intradermal, or Fluzone High Dose vaccine [ Time Frame: Day 0 and Day 21 post vaccination ]
    Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) and seroprotection and seroconversion will be calculated.
  • Seroprotection and seroconversion to vaccine antigens following vaccination with Fluzone® influenza virus vaccines [ Time Frame: Day 0 and Day 21 post vaccination ]
    Seroprotection is defined as a titer ≥ 40 (l/dil) at pre vaccination and at 21days after vaccination. Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at 21 days after vaccination
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults
Official Title  ICMJE Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines, 2013-2014 Formulations
Brief Summary

The aim of the study is describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age, and to describe the safety and immunogenicity of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.

Primary Objective:

  • To describe the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.

Observational objectives:

  • To describe the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2013-2014 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age.
  • To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
  • To submit sera from selected subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Detailed Description

Participants 18 to < 65 years of age on enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone Intradermal vaccine. Participants ≥ 65 years of age at enrollment will be randomized to receive either Fluzone Quadrivalent or Fluzone High-Dose vaccine.

Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE and Serious adverse event information will be collected from Visit 1 to Visit 2. Total duration of participation in the study is approximately 21 days.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),
    0.5 mL, Intramuscular
    Other Name: Fluzone® Quadrivalent, Influenza Virus Vaccine
  • Biological: Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation),
    0.1 mL, Intradermal
    Other Name: Fluzone® Intradermal, Influenza Virus Vaccine
  • Biological: Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)
    0.5 mL, Intramuscular
    Other Name: Fluzone® High-Dose, Influenza Virus Vaccine
Study Arms  ICMJE
  • Experimental: Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)
    Participants age 18 to < 65 years randomized to receive a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
    Intervention: Biological: Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),
  • Experimental: Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)
    Participants age 18 to < 65 years randomized to receive a dose of Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation)
    Intervention: Biological: Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation),
  • Experimental: Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)
    Participants age ≥ 65 years randomized to receive a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
    Intervention: Biological: Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),
  • Experimental: Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)
    Participants age ≥ 65 years randomized to receive a dose of Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)
    Intervention: Biological: Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2013)
208
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is ≥ 18 years of age on the day of inclusion
  • Informed consent form 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 Visit 2.
  • 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
  • Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
  • Prior vaccination with any 2013-2014 formulation of influenza vaccine
  • Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent, Fluzone Intradermal, 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 Prescribing Information)
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
  • 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 ≥ 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01946438
Other Study ID Numbers  ICMJE GRC52
U1111-1127-7587 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date September 2014

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