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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