Evidence for safety in females 24 to 45 years
STUDY DETAILS					SUMMARY
Study	Vaccine	Study Design	Participants	Summary of Key Findings	Level of Evidence	Quality
Munoz et al. (85)	Gardasil®	Randomized, double-blind, placebo controlled trial	n=3819 24 to 45 years of age; 38 international sites	98% (n=1242) were anti-HPV type 6 seropositive; 98% (n=1238) anti-HPV type 11 seropositive; 99% (n=1264) were anti-HPV type 16 seropositive and 97% (n=1406) anti-HPV type 18 seropositive at month 7 following three doses of quadrivalent HPV vaccine (Gardasil®) at day 1, month 2 and month 6.	Level I	Good
Block et al. (145)	Gardasil®	Randomized, double-blind, placebo-controlled 3 doses at 0, 2 and 6 months Meta-analysis of Protocols 016, 018	n=21 480 females (9 to 26 years) and males (9 to 16 years) who received at least one dose of vaccine or placebo.	Injection-site AEs: -Most mild-moderate in intensity (78%). -Most common were pain (81.3%), swelling (24.2%) and erythema (23.6%) among vaccine recipients. -Significantly higher among vaccine versus placebo recipients; aluminum-containing (83% versus 77%, p<0.05) and non-aluminum containing (83% versus 49%, p<0.05). Systemic AEs: -Comparable between vaccine and placebo groups: headache (26% versus 28%), pyrexia (13% versus 11%) and nausea (6% versus 6%). Eight treatment-related adverse events (six in the vaccine group and two in the placebo group) 18 deaths, all unrelated	Level I	Good