Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

33096 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2020-05-31

Brief Summary

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Primary Objective:

To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations.

Secondary Objective:

* To assess the clinical relative effectiveness of QIV-HD as compared to QIV-SD in prevention of:
* inpatient hospitalization for selected circulatory and respiratory causes
* death, either all-cause or cardiovascular or respiratory causes
* inpatient hospitalization (using primary and secondary discharge diagnoses)
* inpatient hospitalization (using admission diagnoses)
* hospital emergency room visits
* primary care visits to physician or
* major acute cardiovascular events (MACE)
* To assess the characteristics of inpatient hospitalization or hospital emergency room visits or primary care visits to physician by QIV-HD and QIV-SD groups.
* To describe the clinical relative effectiveness of QIV-HD as compared to QIV-SD:
* by age group and by group with specific comorbidities
* for different periods of observation
* To describe all serious adverse events (SAEs) (including adverse event of special interest \[AESIs\]) for all subjects in both QIV-HD and QIV-SD groups.

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Detailed Description

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Study duration per participant was 1 day of screening and vaccination. The study was planned to be conducted over a period of 3 influenza seasons beginning in 2019-2020. The vaccination period was from October to December.

Conditions

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Influenza (Healthy Volunteers)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Modified double-blind: the participants, the outcome assessors in the hospitals and outpatient care, the Investigators, and the Sponsor will remain blinded to the vaccine assignment in order to avoid any bias in reporting and evaluating illnesses or SAEs. An unblinded qualified trial staff member will administer the appropriate vaccine.

Study Groups

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Group 1: QIV-HD

Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.

Group Type EXPERIMENTAL

Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD)

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular

Group 2: QIV-SD

Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), IM at Day 0.

Group Type ACTIVE_COMPARATOR

Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD)

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular

Interventions

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Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD)

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular

Intervention Type BIOLOGICAL

Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD)

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Efluelda® VaxigripTetra®

Eligibility Criteria

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Inclusion Criteria

\- Aged 65 years or older on the day of inclusion ("65 years" means from the day of the 65th birthday).

Exclusion Criteria

* Participation at the time of study enrollment (or in the 4 weeks \[28 days\] 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.
* Previous vaccination against influenza (in the preceding 6 months) with either the study vaccines or another vaccine.
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes