REACTOGENICITY OF GLAXOSMITHKLINE’S AS04-ADJUVANTED CERVICAL CANCER VACCINE CO-ADMINISTERED WITH COMBINED DIPHTHERIA–TETANUS–ACELLULAR PERTUSSIS-INACTIVATED POLIOVIRUS VACCINE IN GIRLS AGED 10–18 YEARS

Background As many countries recommend human papillomavirus (HPV) vaccination in adolescent girls at an age when other vaccines are routinely administered, co-administration of this vaccine with other adolescent vaccines would be convenient. This study (108464/NCT00426361) evaluated the reactogenicity of HPV-16/18 AS04 adjuvanted vaccine (Cervarix, GlaxoSmithKline) co-administered with diphtheria–tetanus–acellular pertussis-inactivated poliovirus vaccine (dTpa-IPV; Boostrix Polio, GlaxoSmithKline). Methods Healthy girls aged 10–18 years were randomly assigned to three groups to receive either HPV-16/18 (n  =  246), dTpa-IPV (n  =  250), or HPV-16/18 vaccine co-administered with dTpa-IPV (n  =  250). Solicited local and general symptoms were recorded for 7 days post-vaccination. Unsolicited symptoms, serious adverse events (SAE), medically significant conditions and new onset of chronic diseases are assessed during the entire study period and reported up to one month post-dose 1. Results Incidence of local solicited symptoms was 25.2–85.0% in the HPV-16/18 group, 30.0–84.0% in the dTpa-IPV group and 31.6–89.2% in the HPV-16/18 plus dTpa-IPV group (grade 3 severity ⩽6.1%, ⩽4.4% and ⩽8.8%, respectively). Respective incidences of most common general solicited symptoms were: fatigue, 29.7%, 35.6%, 41.2%; headache, 29.7%, 33.2%, 38.0%; myalgia, 28.9%, 35.2%, 38.4%. Incidence of grade 3 general solicited symptoms was low in all groups (⩽1.2%, ⩽2.8% and ⩽3.6%, respectively). Respective incidence of unsolicited symptoms was 22.2%, 23.5% and 17.5%. No subjects withdrew due to adverse events and no vaccine-related SAE were reported. Conclusions Cervarix has similar reactogenicity to Boostrix Polio, another adolescent vaccine licensed and in general use. Co-administration of these two vaccines was generally well tolerated and did not increase the frequency of solicited local and general symptoms.