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

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Influenza (Healthy Volunteers)

Treatments: Biological: Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD); Biological: Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04137887

QHD00012

2019-001401-25 (EudraCT Number)

U1111-1217-2654 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33,096 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33,096 participants in 2 patient groups

Group 1: QIV-HD

Experimental group

Description:

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

Treatment:

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

Group 2: QIV-SD

Active Comparator group

Description:

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

Treatment:

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