CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,100 enrolled
Drug / intervention
High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD) +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/NCT04498832
NCT04498832Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of High-Dose Quadrivalent Influenza Vaccine (SP0178) Administered by Intramuscular Route Versus Standard-Dose Quadrivalent Influenza Vaccine by Subcutaneous Route in Subjects 60 Years of Age and Older in Japan

Sanofi Pasteur, a Sanofi Company·interventional·Posted Aug 5, 2020·Updated Sep 23, 2025

In Brief

A Phase 3 clinical trial evaluating High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD) and Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD) for Influenza Immunization and Healthy Volunteers. Completed, enrolled 2,100 participants across 10 sites.

Detailed Summary

Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition \[HAI\] geometric mean titers \[GMTs\] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants. Secondary Objective: * To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants. * To describe the safety profile of all participants in each study group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Immunization, Healthy Volunteers
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedAug 5, 2020
Enrollment StartOct 21, 2020
Primary CompletionJan 14, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.9 years ago

Interventions

High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)biological

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

Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)biological

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