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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

NCT04137887 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33096

Last updated 2025-09-17

Study results available
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Summary

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.

Conditions

  • Influenza (Healthy Volunteers)

Interventions

BIOLOGICAL

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

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

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2020-05-31
Completion
2020-05-31
FDA Drug
Yes

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137887 on ClinicalTrials.gov