A PROSPECTIVE, SINGLE-ARM, OPEN-LABEL, NON-RANDOMIZED, PHASE IIA TRIAL OF A NONAVALENT PROPHYLACTIC HPV VACCINE TO ASSESS IMMUNOGENICITY OF A PRIME AND DEFERRED-BOOSTER DOSING SCHEDULE

拟议的临床试验将评估在接种疫苗后18个月的随访期内，在延迟加强剂量之前，主要剂量的非疫苗HPV疫苗是否能在美国9-12岁的女孩中诱导持久和稳定的免疫反应。 这将是一项前瞻性、单臂、开放标签、非随机、IIA期试验，将在9-12岁的女孩中评估非疫苗预防性HPV疫苗的主要和延期加强剂量方案的免疫原性。同时，还将招募一组同时接受标准剂量计划疫苗接种的9-12岁女孩，以进行二次免疫反应比较。

The proposed clinical trial will evaluate if a prime dose of the nonavalent HPV vaccine induces persistent and stable immune responses in 9-12 year old girls in the United States over 18 months post-vaccination follow-up period, before deferred booster doses are administered. It will be a prospective, single-arm, open-label, non-randomized, phase IIA trial that will assess immunogenicity of the prime and deferred-booster dosing schedule of the nonavalent prophylactic HPV vaccine among 9-12 year-old girls. A concurrent reference group of 9-12 year old girls receiving a standard dose schedule of the vaccine will also be enrolled for secondary comparison of the immune responses.