A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

Update Il y a 4 ans
Reference: NCT02562508

Woman Man

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Extract

This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).


Inclusion criteria

  • cervical intraepithelial neoplasia,cervical cancer,Vaginal Intraepithelial Neoplasia,Vulvar intraepithelial neoplasia,Persistent Infection

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