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

February 5, 2018 updated by: Sanofi Pasteur, a Sanofi Company

Safety and Immunogenicity Trial of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Subjects Aged 65 Years and Older

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

792

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Milford, Connecticut, United States, 06460
    • Florida
      • Coral Gables, Florida, United States, 33134
    • Kansas
      • Wichita, Kansas, United States, 67207
    • Missouri
      • Saint Louis, Missouri, United States, 63104
    • New York
      • Rochester, New York, United States, 14609
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • Tennessee
      • Nashville, Tennessee, United States, 37212
    • Utah
      • Salt Lake City, Utah, United States, 84109
      • West Jordan, Utah, United States, 84088

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • TIV HD2
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 Names:
  • TIV HD2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 up to 6 months post-vaccination
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
Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 28 post-vaccination
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.
Day 28 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

April 4, 2016

Study Completion (ACTUAL)

April 4, 2016

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (ESTIMATE)

September 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QHD01
  • U1111-1161-2450 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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