This case study outlines a Phase IV, randomised, single-blind, placebo-controlled, multi-centre study to evaluate the immunogenicity of pneumococcal and influenza vaccines in adult subjects with rheumatoid arthritis receiving a study drug or placebo.

PRA was contracted by a large biotech client to evaluate the immunogenicity of a flu vaccine in adult subjects with rheumatoid arthritis. Early on, PRA realised the potentials for study delays and so began discussing recruitment planning strategies with the client.

From the start, the PRA study team faced a shortened enrolment period and other timeline challenges, including the protocol’s late delivery, as well as problems with the vaccine’s availability.

The study team also realised that the shortened enrolment period would limit the number of patients eligible for recruitment because many would have had already received their seasonal flu and/or H1N1 vaccinations.