Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    GRC55
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02258334
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : October 19, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 2, 2014
First Posted Date  ICMJE October 7, 2014
Results First Submitted Date  ICMJE September 16, 2015
Results First Posted Date  ICMJE October 19, 2015
Last Update Posted Date October 19, 2015
Study Start Date  ICMJE October 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 up to Day 7 post-vaccination ]
Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Fluzone® Influenza vaccines [ Time Frame: Day 0 up to Day 21 post-vaccination ]
Solicited injection site: Pain, Redness, Swelling, Induration, and Ecchymosis. Solicited systemic reaction: 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 NCT02258334 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
  • Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine. [ Time Frame: Day 0 (pre-vaccination) and Day 21 post-vaccination ]
    Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
  • Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine. [ Time Frame: Day 0 (pre-vaccination) and Day 21 post-vaccination ]
    Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.
  • Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine [ Time Frame: Day 21 post-vaccination ]
    Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was 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 21 days after vaccination.
  • Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine [ Time Frame: Day 21 post-vaccination ]
    Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
  • Geometric mean titers of antibodies to vaccine antigens following vaccination with Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose influenza vaccine [ Time Frame: Day 0 and Day 21 post-vaccination ]
    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 determined.
  • Seroprotection with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose influenza vaccine [ Time Frame: Day 0 and Day 21 post-vaccination ]
    Seroprotection defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 21 days after vaccination.
  • Seroconversion with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose influenza vaccine [ Time Frame: Day 21 post-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 Vaccines in Adults
Official Title  ICMJE Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines, 2014-2015 Formulations
Brief Summary

The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65 years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age.

Objectives:

  • To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age.

Observational objectives:

  • To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the 2014-2015 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.
Detailed Description Adults 18 to < 65 years of age will be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® Intradermal vaccine. Adults ≥ 65 years of age will also be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® High-Dose vaccine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Fluzone® Quadrivalent vaccine, 2014-2015 formulation
    0.5 mL, Intramuscular
    Other Name: Fluzone® Quadrivalent vaccine
  • Biological: Fluzone I®ntradermal vaccine, 2014-2015 formulation
    0.1 mL, Intradermal
    Other Name: Fluzone® Intradermal vaccine
  • Biological: Fluzone High Dose vaccine, 2014-2015 formulation
    0.5 mL, Intramuscular
    Other Name: Fluzone® High Dose, vaccine
Study Arms  ICMJE
  • Experimental: Fluzone® Quadrivalent vaccine Group 1
    Adults 18 to < 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine
    Intervention: Biological: Fluzone® Quadrivalent vaccine, 2014-2015 formulation
  • Experimental: Fluzone® Intradermal vaccine Group 2
    Adults 18 to < 65 years of age randomly assigned to receive an intradermal injection of Fluzone® Intradermal vaccine
    Intervention: Biological: Fluzone I®ntradermal vaccine, 2014-2015 formulation
  • Experimental: Fluzone® Quadrivalent vaccine Group 3
    Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine
    Intervention: Biological: Fluzone® Quadrivalent vaccine, 2014-2015 formulation
  • Experimental: Fluzone® High-Dose vaccine Group 4
    Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® High-Dose vaccine
    Intervention: Biological: Fluzone High Dose vaccine, 2014-2015 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: October 2, 2014)
208
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date November 2014   (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 2014-2015 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, 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 an 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 an 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 NCT02258334
Other Study ID Numbers  ICMJE GRC55
U1111-1143-8931 ( 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 2015

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