Table 6.

Efficacy or effectiveness of vaccination against human papillomavirus in males: infections in participants who were seronegative and PCR-negative at enrolment

Study	Design	No. of events/no. of participants		Unadjusted estimate (95% CI)	Confounder-adjusted estimate (95% CI)	VE (95% CI)
		Vaccine	Control
Incident anogenital infection
HPV 16
Giuliano et al. (2011) [32]a	RCT	62/2337.7 pyrs	103/2287.8 pyrs	NR	NA	41.1% (18.5–57.7%)
HPV 18
Giuliano et al. (2011) [32]a	RCT	25/2441.3 pyrs	66/2440.6 pyrs	NR	NA	62.1% (39.2–77.1%)
Persisting anogenital infection
HPV 16
Giuliano et al. (2011) [32]a	RCT	9/2382.4 pyrs	41/2312.9 pyrs	NR	NA	78.7% (55.5–90.9%)
HPV 18
Giuliano et al. (2011) [32]a	RCT	1/2461.9 pyrs	25/2453.5 pyrs	NR	NA	96% (75.6–99.9%)
Incident anal infection
HPV 16
Palefsky et al. (2011) [33]a	RCT	6/326 pyrs	25/322.8 pyrs	NR	NA	76.2% (40.7–92%)
HPV 18
Palefsky et al. (2011) [33]a	RCT	0/346.3 pyrs	16/375.1 pyrs	NR	NA	100% (71.9–100%)
Persisting anal infection
HPV 16
Palefsky et al. (2011) [33]a	RCT	1/331.5 pyrs	16/329.9 pyrs	NR	NA	93.8% (60.0–99.9%)
HPV 18
Palefsky et al. (2011) [33]a	RCT	0/346.3 pyrs	10/376.2 pyrs	NR	NA	100% (51.5–100%)

NA not applicable, NR not reported, pyrs person-years, VE vaccine efficacy or effectiveness

^aVE as reported in the primary study