CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,539 enrolled
Drug / intervention
Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04024228
NCT04024228Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jul 18, 2019·Updated Sep 12, 2025

In Brief

A Phase 3 clinical trial evaluating Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD) and High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation for Influenza Immunization and Healthy Volunteers. Completed, enrolled 1,539 participants across 17 sites in 6 countries.

Detailed Summary

Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective: * Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). * Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Immunization, Healthy Volunteers
CountriesBelgium, France, Germany, Italy, Netherlands, Poland
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 18, 2019
Enrollment StartOct 28, 2019
Primary CompletionJan 9, 2020
Study CompletionJun 5, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.0 years ago

Interventions

Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD)biological

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

High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulationbiological

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