Open-Label Influenza Vaccine Evaluation

Completed 179 enrolled Marshfield Clinic Research Foundation Centers for Disease Control and Prevention · collab

RandomizedParallel-groupOpen-labelBasic science

Summary

This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.

Timeline

Start: 2016-09
Primary completion: 2018-04
Completion: 2018-09

Publications

McLean HQ, Levine MZ, King JP, Flannery B, Belongia EA. Serologic response to sequential vaccination with enhanced influenza vaccines: Open label randomized trial among adults aged 65-74 years. Vaccine. 2021 Dec 3;39(49):7146-7152. doi: 10.1016/j.vaccine.2021.10.072. Epub 2021 Nov 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluad	Vaccine	0.5 ml	Intramuscular
Comparator	Flublok	Vaccine	0.5 ml	Intramuscular
Comparator	Fluvirin	Vaccine	0.5 ml	Intramuscular
Comparator	Influenza Virus Vaccine	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.