CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 175 enrolled
Drug / intervention
QIV-HD by IM +2 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/NCT03233217
NCT03233217Phase 2Completed
CompareCT.gov

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular or Subcutaneous Route in Participants Aged 65 Years and Older in Japan

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jul 28, 2017·Updated Apr 4, 2022

In Brief

A Phase 2 clinical trial evaluating QIV-HD by IM, QIV-SD by SC, and 1 other intervention for Influenza. Completed, enrolled 175 participants across 2 sites.

Detailed Summary

This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to \[\>=\] 65 years).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesJapan
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 28, 2017
Enrollment StartSep 15, 2017
Primary CompletionNov 28, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.9 years ago

Interventions

QIV-HD by IMbiological

IM, injected into the upper arm (deltoid area)

QIV-SD by SCbiological

SC, injected into the upper arm (posterior region)

QIV-HD by SCbiological

SC, injection into the upper arm (posterior region)