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    Home > Medical News > Medicines Company News > Ruike Biologics Announces the Latest Progress of Phase III Clinical Development of Recombinant Nine-valent HPV Vaccine

    Ruike Biologics Announces the Latest Progress of Phase III Clinical Development of Recombinant Nine-valent HPV Vaccine

    • Last Update: 2022-08-20
    • Source: Internet
    • Author: User
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    Jiangsu Recco Biotechnology Co.


    The phase III clinical trial of REC603 in China consists of three parts: the main efficacy trial, the immune bridging trial in small age groups, and the immunogenicity comparison trial with Gardasil? For 16,050 cases:

    Main efficacy trial: In healthy women aged 18-45 years, evaluating the protective efficacy of high-grade cervical, vulvar, and vaginal high-grade intraepithelial neoplasia and above lesions associated with high-risk HPV infection contained in the experimental vaccine is the primary efficacy endpoint.


    Small age group immune bridging trial: evaluating the non-inferiority of serum neutralizing antibodies in healthy women aged 9-17 years compared with healthy women aged 18-45 at 1 month after full-scale vaccination with the experimental vaccine

    Immunogenicity Comparison Trial with Gardasil® 9: To evaluate the non-inferiority of serum neutralizing antibodies compared with Gardasil® 9 at 1 month after full vaccination with the test vaccine in healthy women aged 16-26 years

    The nine-valent HPV vaccine can prevent approximately 90% of cervical cancers and 90% of anal and genital warts, and is widely regarded as the most effective vaccine against HPV


    Jiangsu Recco Biotechnology Co.


    The phase III clinical trial of REC603 in China consists of three parts: the main efficacy trial, the immune bridging trial in small age groups, and the immunogenicity comparison trial with Gardasil? For 16,050 cases:

    Main efficacy trial: In healthy women aged 18-45 years, evaluating the protective efficacy of high-grade cervical, vulvar, and vaginal high-grade intraepithelial neoplasia and above lesions associated with high-risk HPV infection contained in the experimental vaccine is the primary efficacy endpoint.


    Small age group immune bridging trial: evaluating the non-inferiority of serum neutralizing antibodies in healthy women aged 9-17 years compared with healthy women aged 18-45 at 1 month after full-scale vaccination with the experimental vaccine

    Immunogenicity Comparison Trial with Gardasil® 9: To evaluate the non-inferiority of serum neutralizing antibodies compared with Gardasil® 9 at 1 month after full vaccination with the test vaccine in healthy women aged 16-26 years

    The nine-valent HPV vaccine can prevent approximately 90% of cervical cancers and 90% of anal and genital warts, and is widely regarded as the most effective vaccine against HPV


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