At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,670 enrolled
Drug / intervention
QIV-HD +2 morebiological
Likely dose
QIV-HD 0.7 mLfrom 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.
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Participants Aged 65 Years and Older
In Brief
A Phase 3 clinical trial evaluating QIV-HD, Licensed TIV-HD1, and 1 other intervention for Influenza. Completed, enrolled 2,670 participants across 36 sites.
Detailed Summary
This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedSep 2017
Primary CompletionNov 2017
Study CompletionApr 2018
TodayJul 2026
First PostedSep 13, 2017
Enrollment StartSep 8, 2017
Primary CompletionNov 2, 2017
Study CompletionApr 19, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.8 years ago
Interventions
QIV-HDbiological
0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.
Licensed TIV-HD1biological
0.5 mL-dose was administered IM into the upper arm area.
Investigational TIV-HD2biological
0.5 mL-dose was administered IM into the upper arm area.