TABLE 2.

Frequencies and proportions of adverse reactions grouped under “no effect” or “mild or moderate effect”^a

Reaction and dose	Effect	No. (%) of subjects observed within 14 days of dose		Pb
		Placebo	OMV vaccine
Pain
1	None	34 (72.3)	27 (60.0)
	Mild/moderate	13 (27.7)	18 (40.0)	0.21*
2	None	25 (75.8)	21 (75.0)
	Mild/moderate	8 (24.2)	7 (25.0)	0.94*
3	None	25 (86.2)	22 (81.5)
	Mild/moderate	4 (13.8)	5 (18.5)	0.72**
Booster	None		13 (72.2)
	Mild/moderate		5 (27.8)
Tenderness
1	None	19 (40.4)	7 (15.6)
	Mild/moderate	28 (59.6)	38 (84.4)	0.01*
2	None	15 (45.5)	14 (50.0)
	Mild/moderate	18 (54.6)	14 (50.0)	0.72*
3	None	16 (55.2)	19 (70.4)
	Mild/moderate	13 (44.8)	8 (29.6)	0.24*
Booster	None		8 (44.4)
	Mild/moderate		10 (55.6)
Erythema
1	None	47 (100.0)	34 (75.6)
	Mild/moderate	0 (0.0)	11 (24.4)	<0.001**
2	None	33 (100.0)	26 (92.9)
	Mild/moderate	0 (0.0)	2 (7.1)	0.21**
3	None	29 (100.0)	23 (85.2)
	Mild/moderate	0 (0.0)	4 (14.8)	0.05**
Booster	None		15 (83.3)
	Mild/moderate		3 (16.7)
Swelling
1	None	47 (100.0)	41 (91.1)
	Mild/moderate	0 (0.0)	4 (8.9)	0.05**
2	None	33 (100.0)	26 (92.9)
	Mild/moderate	0 (0.0)	2 (7.1)	0.21**
3	None	29 (100.0)	24 (88.9)
	Mild/moderate	0 (0.0)	3 (11.1)	0.11**
Booster	None		17 (94.4)
	Mild/moderate		1 (6.6)

^aResults are shown for all study participants. Local reaction assessments were made in accordance with the following grading system: for pain, mild (does not interfere with daily living activity), moderate (interferes with daily living activity or requires repeated use of pain relievers), and severe (prevents or disrupts daily living activity or requires repeated use of narcotic pain relievers, clinician appointment, or hospital visit); for tenderness, mild (mild pain to touch), moderate (pain with movement), and severe (significant pain at rest); and for erythema and swelling, mild (up to 5 cm), moderate (5.1 to 10 cm), and severe (>10 cm).

^b*, Pearson's chi-square test; **, Fisher's exact test.