Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

Sanofi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Influenza

Treatments: Biological: QIV-SD by SC; Biological: QIV-HD by IM; Biological: QIV-HD by SC

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03233217

QHD00008

U1111-1183-5525 (Other Identifier)

DFI15130 (Other Identifier)

Details and patient eligibility

About

This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to [>=] 65 years).

Full description

This phase I/II, randomized, modified double-blind, multi-center study was conducted in 175 healthy Japanese adults aged 65 years and older to describe the safety profile and immune responses (geometric mean titers and seroconversion for the 4 common strains at 28 days post-vaccination) of the QIV-HD administered by intramuscular (IM) and subcutaneous (SC) methods. A local standard-dose Quadrivalent Influenza Vaccine (QIV-SD) administered by SC method served as a control arm.

Enrollment: 175 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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 study procedures.

Exclusion criteria

• Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccination with live vaccines within the past 27 days preceding the study vaccination or any vaccination with inactivated vaccines within the past 6 days preceding the study vaccination, or planned receipt of any vaccine prior to Visit 3.
• Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine.
• 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 eggs, chicken proteins, or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study 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.
• Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the study conduct or completion.
• Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion.
• 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.
• Personal or family history of Guillain-Barré syndrome.
• Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and have been disease free for >=5 years).
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >=37.5°Celsius). A prospective participant were not be included in the study until the condition had resolved or the febrile event had subsided.
• History of convulsions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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175 participants in 5 patient groups

Cohort 1: QIV-HD by IM

Experimental group

Description:

Participants were randomized to receive a single 0.7-milliliter (mL) injection of QIV-HD by IM route on Day 0.

Treatment:

Biological: QIV-HD by IM

Cohort 1: QIV-HD by SC

Experimental group

Description:

Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.

Treatment:

Biological: QIV-HD by SC

Cohort 2: QIV-HD by IM

Experimental group

Description:

Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.

Treatment:

Biological: QIV-HD by IM

Cohort 2: QIV-HD by SC

Experimental group

Description:

Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.

Treatment:

Biological: QIV-HD by SC

Cohort 2: QIV-SD by SC

Active Comparator group

Description:

Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.

Treatment:

Biological: QIV-SD by SC