CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,484 enrolled
Drug / intervention
Quadrivalent Influenza Vaccine (QIV) +2 morebiological
Likely dose
Quadrivalent Influenza Vaccine (QIV) 0.5 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.

Search/NCT02214225
NCT02214225Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Multicenter, Double-blinded Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (CSL QIV) in Comparison With a US Licensed 2014/2015 Trivalent Influenza Vaccine (CSL TIV-1), and a Trivalent Influenza Vaccine Containing the Alternate B Strain (CSL TIV-2), in Adults Aged 18 Years and Above.

Seqirus·interventional·Posted Aug 12, 2014·Updated Mar 13, 2017

In Brief

A Phase 3 clinical trial evaluating Quadrivalent Influenza Vaccine (QIV), Trivalent Influenza Vaccine (TIV-1), and 1 other intervention for Influenza, Human. Completed, enrolled 3,484 participants across 33 sites.

Detailed Summary

This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 12, 2014
Enrollment StartAug 1, 2014
Primary CompletionNov 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.9 years ago

Interventions

Quadrivalent Influenza Vaccine (QIV)biological

One 0.5 mL intramuscular dose into the deltoid muscle

Trivalent Influenza Vaccine (TIV-1)biological

One 0.5 mL intramuscular dose into the deltoid muscle.

Trivalent Influenza Vaccine (TIV-2)biological

One 0.5 mL intramuscular dose into the deltoid muscle.