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

NCT02553343 | Completed Phase 2

• 2 other identifiers: QHD01U1111-1161-2450
• Study Type: interventional
• Target: 792
• Locations: 1 country
• Sites: 9

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.

Conditions

Influenza

Keywords

Influenza; High-Dose Quadrivalent Influenza Vaccine; High-Dose Trivalent Influenza Vaccine

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Day 28 post-vaccination

Secondary Outcomes (2)

• Seroconversion with respect to vaccine antigens following vaccination with Fluzone High-dose quadrivalent influenza vaccine or High-dose trivalent influenza vaccine

  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

  Day 28 post-vaccination

Study Arms (4)

QIV HD1 Group

EXPERIMENTAL

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

QIV HD2 Group

EXPERIMENTAL

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

TIV HD1 Group

ACTIVE COMPARATOR

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

TIV HD2 Group

ACTIVE COMPARATOR

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

Interventions

High-dose quadrivalent influenza virus vaccine BIOLOGICAL

0.5 mL, Intramuscular (IM), injected into the deltoid area

Also known as: High-dose quadrivalent influenza virus vaccine (QIV HD1)

QIV HD1 Group

High-dose influenza virus vaccine BIOLOGICAL

0.5 mL, Intramuscular (IM), injected into the deltoid area

Also known as: High-dose quadrivalent influenza virus vaccine (QIV HD2)

QIV HD2 Group

High-dose trivalent inactivated influenza vaccine BIOLOGICAL

0.5 mL, Intramuscular (IM), injected into the deltoid area

Also known as: Fluzone® High-Dose, TIV HD1

TIV HD1 Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Informed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (9)

Unknown Facility

Milford, Connecticut, 06460, United States

Location

Unknown Facility

Coral Gables, Florida, 33134, United States

Location

Unknown Facility

Wichita, Kansas, 67207, United States

Location

Unknown Facility

St Louis, Missouri, 63104, United States

Location

Unknown Facility

Rochester, New York, 14609, United States

Location

Unknown Facility

Warwick, Rhode Island, 02886, United States

Location

Unknown Facility

Nashville, Tennessee, 37212, United States

Location

Unknown Facility

Salt Lake City, Utah, 84109, United States

Location

Unknown Facility

West Jordan, Utah, 84088, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: April 4, 2016
• Study Completion: April 4, 2016
• Last Updated: February 9, 2018

Record last verified: 2018-02

Locations

US (9)