Evidence for Immunogenicity, Safety in 10-14 year old females
STUDY DETAILS					SUMMARY
Study	Vaccine	Study Design	Participants	Summary of Key Findings	Level of Evidence	Quality
HPV012 (133)	Cervarix™	Randomized trial To compare the immunogenicity and safety in early adolescent females to 15–25 year old females in whom vaccine efficacy has been demonstrated	Females 10 to 25 years =773	Females 10-14 years and 15-25 years achieved 100% seroconversion for HPV 16 and 18. Participants 10–14 years of age were noninferior to those 15–25 years in terms of HPV 16 and 18 seroconversion rates and had approximately twice as high GMTs	Level II-1	Good
HPV013 (Medina et al)	Cervarix™	Observer-blinded, Randomized Controlled Trial To assess safety and immunogenicity in adolescent girls	Females 10 to 14 years n=2067	Up to month 7, 11 girls in the HPV-16/18 vaccine group reported 14 SAEs and 13 girls in the control group reported 15 SAEs. The difference in SAE incidence between groups was 20% (95% CI, _.78, 1.20). The incidence of solicited local and general symptoms up to 7 days postvaccination was moderately higher with the HPV-16/18 vaccine than with control. All girls seroconverted for both antigens after three doses of the HPV-16/18 vaccine. GMTs were 19,882.0 and 8,262.0 EU/mL for anti-HPV-16 and -18 antibodies, respectively, in initially seronegative girls.	Level I	Good
HPV013	Cervarix™	Multicentric, double-blinded, randomized, controlled study To evaluate safety and immunogenicity. Havrix (HAV) was used as a control vaccine.	Females 10 to 14 years n=741	Between Month 0 and Month 12, SAEs were reported for 22 (2.1%) and 23 (2.2%) subjects in the HPV and HAV groups, respectively. Between Month 12 and Month 18, SAEs were reported for 7 (1.1%) and 2 (0.3%) subjects in the HPV and HAV groups, respectively; from Month 18 to 24, SAEs were reported for 8 (1.3%) and 5 (0.9%) subjects in the HPV and HAV groups, respectively. From Month 24 to 36, SAEs were reported for 10 (1.7%) subjects and from Month 36 to 48, SAEs were reported for 15 (2.6%) subjects in the HPV Group. In the HPV Group, at Month 7, all subjects were seropositive for anti-HPV-16 and for anti-HPV-18 with GMTs of 20018.1 and 8359.4, respectively; at Month 48, all subjects were seropositive for anti-HPV-16 and for anti-HPV-18 with GMTs of 2395.8 and 885.6, respectively.	Level I	Assessment pending peer-reviewed publication