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A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older

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ClinicalTrials.gov Identifier: NCT02553343
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of the study is to assess the safety and immunogenicity of two formulations of the high-dose quadrivalent influenza vaccine compared to the licensed high-dose trivalent influenza vaccine control in healthy elderly subjects aged 65 years of age and above.

Primary objectives:

  • To describe the safety profile of all subjects in each study group.
  • To demonstrate that the high-dose quadrivalent influenza vaccine induces an immune response (as assessed by HAI geometric mean titers (GMTs) that is non-inferior to responses induced by the licensed high-dose trivalent influenza vaccine for the 3 common virus strains at 28 days post-vaccination.

Secondary objectives:

  • To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by seroconversion and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the licensed high-dose trivalent influenza vaccine.
  • To describe post-vaccination immunogenicity for the 4 virus strains (as assessed by GMTs, seroconversion, and seroprotection) for subjects who receive the high-dose quadrivalent influenza vaccine and the investigational high-dose trivalent influenza vaccine.

Condition or disease Intervention/treatment Phase
Influenza Biological: High-dose quadrivalent influenza virus vaccine Biological: High-dose influenza virus vaccine Biological: High-dose trivalent inactivated influenza vaccine Phase 2

Detailed Description:
All eligible participants will be randomized to receive a single injection of either one of the high-dose quadrivalent influenza vaccine formulations or one of the high-dose trivalent influenza vaccines at Day 0. They will provide blood samples for hemagglutination inhibition (HAI) testing. Safety information as solicited, unsolicited reactions, serious adverse events, including adverse events of special interest will be collected in the trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 792 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Trial of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Subjects Aged 65 Years and Older
Study Start Date : September 2015
Actual Primary Completion Date : April 4, 2016
Actual Study Completion Date : April 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: QIV HD1 Group
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 1)
Biological: High-dose quadrivalent influenza virus vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
Other Name: High-dose quadrivalent influenza virus vaccine (QIV HD1)

Experimental: QIV HD2 Group
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of High-Dose quadrivalent influenza vaccine (formulation 2)
Biological: High-dose influenza virus vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
Other Name: High-dose quadrivalent influenza virus vaccine (QIV HD2)

Active Comparator: TIV HD1 Group
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of licensed High Dose trivalent influenza vaccine
Biological: High-dose trivalent inactivated influenza vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
Other Name: Fluzone® High-Dose, TIV HD1

Active Comparator: TIV HD2 Group
Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of one dose of investigational High-Dose trivalent influenza vaccine
Biological: High-dose trivalent inactivated influenza vaccine
0.5 mL, Intramuscular (IM), injected into the deltoid area
Other Name: TIV HD2




Primary Outcome Measures :
  1. Number of participants reporting solicited injection site and systemic events, unsolicited adverse events and serious adverse events following vaccination with a dose of Fluzone influenza vaccines [ Time Frame: Day 0 up to 6 months 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

  2. Hemagglutination inhibition (HAI) antibody titers to influenza virus antigens following vaccination with Fluzone High Dose quadrivalent influenza vaccine or High Dose trivalent influenza vaccine [ Time Frame: Day 28 post-vaccination ]

Secondary Outcome Measures :
  1. Seroconversion with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine [ Time Frame: Day 28 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 28 days after vaccination.

  2. Seroprotection with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine [ Time Frame: Day 28 post-vaccination ]
    Seroprotection is defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after vaccination.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 65 years 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:

  • Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2
  • Vaccination against influenza in the past 6 months
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • 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)
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on investigator's judgment
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Substance abuse that, in the opinion of the investigator, might interfere with the trial conduct or completion
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed trial
  • Personal or family history of Guillain-Barré syndrome
  • Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and subjects who have a history of neoplastic disease and have been disease free for ≥ 5 years)
  • Known allergy to iodinated radiocontrast media
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective subject should not be included in the trial until the condition has resolved or the febrile event has subsided.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553343


Locations
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United States, Connecticut
Milford, Connecticut, United States, 06460
United States, Florida
Coral Gables, Florida, United States, 33134
United States, Kansas
Wichita, Kansas, United States, 67207
United States, Missouri
Saint Louis, Missouri, United States, 63104
United States, New York
Rochester, New York, United States, 14609
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Nashville, Tennessee, United States, 37212
United States, Utah
Salt Lake City, Utah, United States, 84109
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02553343     History of Changes
Other Study ID Numbers: QHD01
U1111-1161-2450 ( Other Identifier: WHO )
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
High-Dose Quadrivalent Influenza Vaccine
High-Dose Trivalent Influenza Vaccine

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs