Evidence for immunogenicity in males 9 to 26 years
STUDY DETAILS					SUMMARY
Study	Vaccine	Study Design	Participants	Summary of Key Findings	Level of Evidence	Quality
Mansi (90)	Gardasil®	Randomized, double-blind, placebo-controlled Three doses at 0, 2 and 6 months Meta-analysis of Pro-tocols 016, 018, 020	Males 16 to 26 years (protocol 020); n=2025 Males 10 to 15 years (protocol 016); n=508 Males 9 to 15 years (protocol 018); n=839	PROTOCOL 020 Seroconversion (at month 7): Anti-HPV type 6 98.9% (98-99) Anti-HPV type 11 99.2% (98-100) Anti-HPV type 16 98.8% (98-99) Anti-HPV type 18 97.4% (96-98) GMTs (at month 7): Anti-HPV type 6 446.0 (422-474) Anti-HPV type 11 624.2 (594-656) Anti-HPV type 16 2402.5 (2271-2542) Anti-HPV type 18 402.2 (380-426) PROTOCOLS 016 and 018 Seroconversion (at month 7): Anti-HPV type 6 99.9% (99.4-100) Anti-HPV type 11 99.9% (99.4-100) Anti-HPV type 16 99.8% (99.2-100) Anti-HPV type 18 99.8% (99.2-100)	Level I	Assessment pending peer-reviewed publication
Block et al. (89)	HPV (types 6, 11, 16 and 18) L1 VLP vaccine (Gardasil®)	Age and gender stratified non-inferiority immunogenicity study (sub-study within randomized, double-blind, multi-dose study) Protocol V501-016	n=1529 (n=506, 10 to 15 year-old females; n=510, 10 to 15 year-old males; n=513, 16 to 23 year-old females)	≥99% seroconversion for all 4 HPV types in each group by month 7 GMTs were non-inferior and 1.7-2.7-fold higher in younger females and males compared to older females	Level I	Good
Reisinger et al. (115)	HPV (types 6, 11, 16 and 18) L1 VLP vaccine (Gardasil®)	Randomized, double-blind, placebo-controlled, multi-centre study Age and gender stratified Protocol V501-018	n=1781 healthy, sexually naive males and females aged 9 to 15 years	≥99% seroconversion for all 4 HPV types in each group by month 7 GMTs and seroconversion non-inferior in males (p<0.001) ≥91.5% seropositive at 18 months	Level 1	Good