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Table 2 Overview of solicited and unsolicited adverse events

From: Immunogenicity and safety of a respiratory syncytial virus fusion protein (RSV F) nanoparticle vaccine in older adults

Group: E A B C D
AE Category Severity/Relationship Placebo N = 60 60 μg + Al N = 40 60 μg N = 40 90 μg + Al N = 40 90 μg N = 40
Verbatim Term n (% of Subjects with Events)
Local Solicited AEsa 14 (23) 17 (43) 9 (23) 17 (43) 15 (38)
 Severe 0 0 0 0 0
  Pain 14 (23) 17 (43) 8 (20) 17 (43) 10 (25)
  Swelling 2 (3) 4 (10) 1 (3) 3 (8) 6 (15)
  Bruising 1 (2) 2 (5) 1 (3) 1 (3) 4 (10)
  Redness 0 0 1 (3) 2 (5) 3 (8)
Solicited Systemic AEsa 22 (37) 12 (30) 6 (15) 16 (40) 10 (25)
 Severe 1 (2) 1 (3) 0 0 1 (3)
  Muscle Pain 6 (10) 6 (15) 4 (10) 7 (18) 5 (13)
  Joint Pain 4 (7) 4 (10) 2 (5) 1 (3) 4 (10)
  Headache 10 (17) 2 (5) 5 (13) 9 (23) 3 (8)
  Fatigue 12 (20) 4 (10) 2 (5) 6 (15) 8 (20)
All Unsolicited AEsb 36 (60) 19 (48) 23 (58) 19 (48) 22 (55)
 Related 6 (10) 1 (3) 0 1 (3) 4 (10)
 Severe 4 (7) 2 (5) 3 (8) 2 (5) 0
 Severe/Related 0 0 0 0 0
 Severe or Related 10 (17) 3 (8) 3 (8) 3 (8) 4 (10)
  Upper Respiratory Tract Infection 6 (10) 2 (5) 3 (8) 1 (3) 2 (5)
  Back Pain 1 (2) 1 (3) 1 (3) 4 (10) 2 (5)
  Myalgia 0 0 1 (3) 2 (5) 3 (8)
  Oropharyngeal Pain 1 (2) 3 (8) 1 (3) 1 (3) 0
  Hypertension 1 (2) 2 (5) 0 2 (5) 1 (3)
  Systolic Hypertension 1 (2) 1 (3) 2 (5) 0 2 (5)
 SAEsb 3 (5) 2 (5) 3 (8) 3 (8) 1 (3)
 MAEsb 21 (35) 11 (28) 14 (35) 8 (20) 14 (35)
 SNMCsb 4 (7) 2 (5) 5 (13) 2 (5) 4 (10)
  1. - Percentages are based on the number of subjects in the Safety Population with the event shown. Subjects with multiple events within a category were counted only once, using the event with the greatest severity (mild, moderate, severe) and/or relationship (possible, probable, definite). An AE was considered treatment-emergent if it began on or after the day 0 vaccination
  2. aOnly includes solicited AEs with an onset within 7 days of the day 0 vaccination. All solicited events were deemed to be related to the test article administered
  3. bIncludes unsolicited AEs with an onset from days 0 to 56; and significant new medical conditions (SNMCs), medically-attended adverse events (MAEs), and serious adverse events (SAEs) with an onset from days 0 to 364. The unsolicited AEs shown are those that occurred in > 2% of subjects (i.e., 4 or more) in an RSV F vaccine group