Volunteers experiencing solicited local and general symptoms after intranasal vaccination.

Table 2 is showing AEs following intramuscular vaccinations and Table 3 for intranasal administrations. Local and general symptoms were assessed from Day 0 to Day 6 after each vaccination and spontaneous AEs that might have occurred after each vaccination were also recorded. The study encompasses a Baseline/week −3 visit and 10 medical visits to monitor occurrence of hematological and biochemical abnormalities in blood. Each symptom was graded for severity and assigned causality relative to the study vaccine. Severity was graded as either absent/none (Grade 0), mild (Grade 1, easily tolerated), moderate (Grade 2, interfere with activity of daily living), or severe (Grade 3, prevented activities of daily living). Redness and swelling at the injection site were graded as follow: 0 = 50 mm. Numbers in bold are vaccine-related symptoms.