Evidence for co-administration with other vaccines
STUDY DETAILS					SUMMARY
Study	Vaccine	Study Design	Participants	Summary of Key Findings	Level of Evidence	Quality
HPV029	Cervarix™	Open, randomized controlled, multicentre study with 3 parallel treatment groups To evaluate immunogenicity and safety of HPV vaccine when co-administered combined hepatitis A and B vaccine (HAB), Twinrix® Paediatric, compared to the administration of these vaccines alone	Females 9 to 15 years =812	Criteria for non-inferiority met for all of the co-primary immunogenicity variables assessing coadministration of HAB vaccine with HPV vaccine At Month 7, the percentage of initially seronegative subjects with anti-HPV-16 antibody titres 8 EL.U/mL was 99.6% in the HPV + HAB Group and 100% in the HPV Group, with antibody GMTs of 22993.5 EL.U/mL in the HPV + HAB Group and 26981.9 EL.U/mL in the HPV Group. The percentage of initially seronegative subjects with anti-HPV-18 antibody titres_ 7 EL.U/mL was 99.6% in the HPV + HAB Group and 100% in the HPV Group, with antibody GMTs of 8671.2 EL.U/mL in the HPV + HAB Group and 11182.7 EL.U/mL in the HPV Group. During the active phase of the study (up to Month 7), unsolicited AEs were reported within the 30-day post-vaccination period in 83 (30.5%) subjects in the HPV + HAB Group, 96 (35.6%) subjects in the HPV Group and 83 (30.6%) subjects in the HAB Group; SAEs were reported for 2 (0.7%) subjects in the HPV + HAB Group, 3 (1.1%) subjects in the HPV Group and 4 (1.5%) subjects in the HAB Group.	Level I	Assessment pending peer-reviewed publication
HPV042	Cervarix™	Open, randomized, controlled multi-centre study with 3 parallel groups. To evaluate immunogenicity and safety of Boostrix® Polio (dTpa-IPV) vaccine co-administered with HPV vaccine compared to the administration of the vaccines alone	Females 10 to 18 years =751	At Month 7, non-inferiority of Cervarix™ when co administered with dTpa-IPV vaccine at Month 0 compared to Cervarix™given alone at Month 0 was demonstrated in terms of anti HPV-16 and anti HPV-18 GMT values. None of the SAEs reported during the whole course of the study were considered to be causally related to the study vaccination. No fatal SAEs were reported throughout the study	Level I	Assessment pending peer-reviewed publication