[Translation] Evaluation of recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 9-valent vaccine (Hansenula spp.) for the prevention of HPV-6/11/16/18/31/33 in healthy women Protocol for a randomized, blinded, parallel-controlled phase III clinical trial of efficacy, immunogenicity, and safety in /45/52/58 infection and related lesions
主要目的:
评价重组人乳头瘤病毒6/11/16/18/31/33/45/52/58 型九价疫苗(汉逊酵母)(全程3剂接种于18-45岁健康女性1个月后预防HPV-6/11/16/18/31/33/45/52/58型感染导致CIN2+宫颈病变的保护效力。
次要目的:
评价3剂接种于9-17岁、16-26岁、18-45岁健康女性的安全性和免疫原性。
评价全程3剂接种于18-45岁健康女性1个月后预防本品所含型别HPV持续感染12个月的保护效力。
评价至少1剂接种于18-45岁健康女性后预防本品所含型别HPV感染后CIN1+宫颈病变的保护效力。
评价至少1剂接种于18-45岁健康女性后预防本品所含型别HPV感染持续6个月(PI6)的保护效力。
评价至少1剂接种于18-45岁健康女性后预防本品所含型别HPV感染导致外生殖器和阴道病变(包括:生殖器疣、VIN1+和VaIN1+)的保护效力。
评价全程3剂接种于9-17岁健康女性1个月后血清抗体指标相较于18-45岁受试者的非劣效性。
评价3剂接种于16-26岁健康女性1个月后血清抗体指标相较于阳性对照组的非劣效性。
[Translation] main purpose:
Evaluation of recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-valent vaccine (Hansenula spp.) (3 doses of whole course inoculated in 18-45 years old healthy women 1 month later to prevent HPV) - Protective efficacy of 6/11/16/18/31/33/45/52/58 infection leading to CIN2+ cervical lesions.
Secondary purpose:
The safety and immunogenicity of 3 doses in healthy women aged 9-17, 16-26, and 18-45 years were evaluated.
To evaluate the protective efficacy of 3 doses of whole course inoculation in healthy women aged 18-45 for 1 month in preventing persistent infection of HPV types contained in this product for 12 months.
To evaluate the protective efficacy of at least 1 dose inoculated to healthy women aged 18-45 to prevent CIN1+ cervical lesions after infection with HPV types contained in this product.
To evaluate the protective efficacy of at least 1 dose inoculated in healthy women aged 18-45 to prevent HPV infection of the type contained in this product for 6 months (PI6).
To evaluate the protective efficacy of at least 1 dose in healthy women aged 18-45 years to prevent genital and vaginal lesions (including: genital warts, VIN1+ and VaIN1+) caused by HPV types contained in this product.
To evaluate the non-inferiority of serum antibody indexes in healthy women aged 9-17 years after vaccination with 3 doses of the whole course compared with subjects aged 18-45 years.
To evaluate the non-inferiority of serum antibody indicators after 3 doses of vaccinated healthy women aged 16-26 years compared with the positive control group for 1 month.