Application of “Systems Vaccinology” to Evaluate Inflammation and Reactogenicity of Adjuvanted Preventative Vaccines

Table 1

Examples of hierarchy of selected medDRA terms used to describe AEFIs in BIOVACSAFE clinical trials.

Preferred term	Higher level term	Higher level group
Abdominal distension	Flatulence bloating and distension	Gastrointestinal signs and symptoms
Abdominal discomfort	Gastrointestinal signs and symptoms not elsewhere coded
Abdominal pain	Gastrointestinal and abdominal pains
Nausea	Nausea and vomiting symptoms
Neutrophil count decreased	White blood cell analyses
Neutrophil count increased