FLU 002 Plus

An International Observational Study to Characterize Adults with Influenza or Other Targeted Respiratory Viruses

Respiratory Virus Outpatient Study (FLU 002 Plus)

(INSIGHT Protocol No. 002, version 4.0, dated 27 August 2013)

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses.

This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.For further details about the Influenza studies, please visit the
INSIGHT website.