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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2017-11-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Safety and tolerability was initially assessed in the first 10 participants in a smaller cohort (Cohort 1). Participants were randomized 1:1 into 2 groups in Cohort 1: QIV-HD by IM route (n=5) and QIV-HD by SC route (n=5).

After review of the local and systemic adverse events, the remaining 165 participants were enrolled (Cohort 2). Participants were randomized 1:1:1 into 3 groups in Cohort 2: QIV-HD by IM route (n=55), QIV-HD by SC route (n=55), and QIV-SD by SC route (n=55).

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

QHD00008 was a modified double-blind study in which only the designated administrator at each study site knew which vaccine was administered to the participants. The participants and the Investigator/Sub-investigator in charge of the safety assessment were blinded in order to decrease the potential bias in safety assessment.

Study Groups

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Cohort 1: QIV-HD by IM

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

Group Type EXPERIMENTAL

QIV-HD by IM

Intervention Type BIOLOGICAL

IM, injected into the upper arm (deltoid area)

Cohort 1: QIV-HD by SC

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

Group Type EXPERIMENTAL

QIV-HD by SC

Intervention Type BIOLOGICAL

SC, injection into the upper arm (posterior region)

Cohort 2: QIV-HD by IM

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

Group Type EXPERIMENTAL

QIV-HD by IM

Intervention Type BIOLOGICAL

IM, injected into the upper arm (deltoid area)

Cohort 2: QIV-HD by SC

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

Group Type EXPERIMENTAL

QIV-HD by SC

Intervention Type BIOLOGICAL

SC, injection into the upper arm (posterior region)

Cohort 2: QIV-SD by SC

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

Group Type ACTIVE_COMPARATOR

QIV-SD by SC

Intervention Type BIOLOGICAL

SC, injected into the upper arm (posterior region)

Interventions

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QIV-HD by IM

IM, injected into the upper arm (deltoid area)

Intervention Type BIOLOGICAL

QIV-SD by SC

SC, injected into the upper arm (posterior region)

Intervention Type BIOLOGICAL

QIV-HD by SC

SC, injection into the upper arm (posterior region)

Intervention Type BIOLOGICAL

Other Intervention Names

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High-Dose Influenza Vaccine Quadrivalent (IM) Standard-Dose Influenza Vaccine Quadrivalent High-Dose Influenza Vaccine Quadrivalent (SC)

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes