MAS-1 Adjuvanted Compared to Unadjuvanted Influenza Vaccines in the Elderly

Summary

This is a Phase 1,2 randomized, double-blind, multi-center, clinical trial, in participants aged 65 years and older, evaluating the immunogenicity and safety of a water-in-oil emulsion adjuvant (MAS-1 adjuvant, Mercia Pharma, Inc, Scarsdale, NY) combined with each of the three reduced HA antigen dose levels of trivalent influenza virus vaccine compared with licensed, unadjuvanted, standard dose trivalent virus (TIV). Immunogenicity for each of the three viral strains (A/H1N1, A/H3N2, and B virus) in the concurrent influenza seasonal vaccine will be assessed.

Timeline

Start

2012-10

Primary completion

2013-11

Completion

2014-06

Outcome

Outcome not reported

Stopped: “FDA hold on the project”

Drugs

Indications

No indication recorded.