H1N1 Vaccine Program

Seamless teamwork among INC Research/inVentiv Health, sponsor and sites results in multinational studies with zero audit findings.

A major pharmaceutical company enlisted INC Research/inVentiv Health to help it facilitate the first study of its kind to be presented to Costa Rican and Argentinean regulatory authorities in response to an immediate public health need: developing and distributing a vaccine effective in protecting against the pandemic 2009 H1N1 virus.

Language barriers presented one set of challenges to be overcome from the outset. But frequent changes to the study’s parameters, a result of continuous talks between the sponsor and regulatory authorities, would prove even more daunting.

While the original trial was already large in scale and constrained by tight timelines, with 800 subjects enrolled in just 14 days, the overall program evolved first from three studies to six, then expanded further to eight studies. Thus, the project became increasingly complex as it progressed, with new enrollees presenting while earlier subjects recorded weekly visits.