Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults

Summary

This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.

Timeline

Start

2017-10-17

Primary completion

2017-12-11

Completion

2018-05-17

Outcome

Met primary endpoint

paper aQIV met non-inferiority criteria for geometric mean titer ratios (GMT ratios) and seroconversion rate (SCR) differences against aTIV. PMID 31635976 ↗

paper The upper bounds of the 2-sided 95% confidence interval (CI) for GMT ratios were <1.5 for all 4 strains PMID 31635976 ↗

paper The upper bounds of the 95% CI of the SCR differences were <10% for all 4 strains PMID 31635976 ↗

Publications

• Essink B, Fierro C, Rosen J, Figueroa AL, Zhang B, Verhoeven C, Edelman J, Smolenov I. Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults. Vaccine. 2020 Jan 10;38(2):242-250. doi: 10.1016/j.vaccine.2019.10.021. Epub 2019 Oct 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	aQIV	Vaccine	—	—
Subject	aTIV-1	Vaccine	—	—
Subject	aTIV-2	Unknown	—	—

Indications