Evaluation of bivalent human papillomavirus (HPV) vaccine safety and tolerability in a sample of 25 year old Tuscan women

Figures & data

Table 1. Adverse reactions registered in the 14 d after immunization

	Number of diary cards with at least one positive response	% (CI 95%)
Adverse reactions
Local pain	514	83,4% (80.3–86.3)
Local swelling	128	20,8% (17.6–24.2)
Local erythema	60	9,7% (7.5–12.4)
Local pruritus	58	9,4% (7.2–12.0)
Fever	90	14,6% (11.9–17.7)

Table 2. Adverse reactions registered in the 14 d following the administration of each dose

	I dose (n = 216)		II dose (n = 209)		III dose (n = 191)
	N	% (CI 95%)	N	% (CI 95%)	N	% (CI 95%)
Local pain	189	87.5 (82.3–91.6)	159	76.1 (69.7–81.7)	166	86.9 (81.3–91.4)
Local swelling	33	15.3 (10.8–20.8)	43	20.6 (15.3–26.7)	52	27.2 (21.1–34.1)
Local pruritus	19	8.8 (5.4- 13.4)	17	8.1 (4.8–12.7)	22	11.5 (7.4–16.9)
Local erythema	18	8.3 (5.0–12.9)	22	10.5 (6.7–15.5)	20	10.5 (6.5–15.7)
Fever	33	15.3 (10.8–20.8)	30	14.4 (9.9–19.9)	27	14.1 (9.5–19.9)

Figure 1. Intensity of adverse reactions after each dose

Table 3. Assessment of difference in tolerability after each dose. Significant values (p < 0.05) are indicated in bold type

Adverse reaction	I dose VS II dose		I dose VS III dose		II dose VS III dose
	χ^2	p	χ^2	p	χ^2	p
Local pain	9.3436	0.002	0.0316	0.859	7.6897	0.006
Local swelling	2.0291	0.154	8.7569	0.003	2.4377	0.118
Local pruritus	0.0601	0.806	0.8291	0.363	1.2990	0.254
Local erythema	0.5992	0.439	0.5473	0.459	0.0003	0.986
Fever	0.0718	0.789	0.1051	0.746	0.0039	0.950

Table 4. Adverse reactions registered in the 14 d following the administration of each dose in the subset of 186 subjects who received all 3 doses of vaccine and completed and returned all three diary cards

	I dose (n = 186)		II dose (n = 186)		III dose (n = 186)
	N	% (CI 95%)	N	% (CI 95%)	N	% (CI 95%)
Local pain	164	88.2 (82.6–92.4)	144	77.4 (70.7–83.2)	161	86.6 (80.8–91.1)
Local swelling	29	15.6 (10.7–21.6)	36	19.4 (13.9–25.8)	50	26.9 (20.7–33.9)
Local pruritus	17	9.1 (5.4–14.2)	12	6.5 (3.4–11.0)	22	11.8 (7.6–17.4)
Local erythema	14	7.5 (4.2–12.3)	19	10.2 (6.3–15.5)	20	10.8 (6.7–16.1)
Fever	30	16.1 (11.1–22.2)	27	14.5 (9.8–20.4)	26	14.0 (9.3–19.8)

Table 5. Assessment of difference in tolerability after each dose in the subset of 186 subjects who received all 3 doses of vaccine and completed and returned all three diary cards. Significant values (p < 0.05) are indicated in bold type

Adverse reaction	I dose VS II dose		I dose VS III dose		II dose VS III dose
	χ^2	p	χ^2	p	χ^2	p
Local pain	7.5487	0.006	0.2192	0.640	5.2610	0.022
Local swelling	0.9135	0.339	7.0874	0.008	2.9644	0.085
Local pruritus	0.9350	0.334	0.7161	0.397	3.2370	0.072
Local erythema	0.8313	0.362	1.1653	0.280	0.0286	0.866
Fever	0.1865	0.666	0.3363	0.562	0.0220	0.882

Figure 2. Comparison between our findings and those previously published with regards to a sample of adolescent girls aged 12–16.¹³

Gasparini R, Bonanni P, Levi M, Bechini A, Boccalini S, Tiscione E, et al. Safety and tolerability of bivalent HPV vaccine: an Italian post-licensure study. Hum Vaccin 2011; 7:Suppl 136 - 46; http://dx.doi.org/10.4161/hv.7.0.14576; PMID: 21266842

 PubMed Web of Science ®Google Scholar