Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years

This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

Inclusion Criteria:

• Written informed consent from the subject prior to enrolment;
• Female between, and including, 18 and 55 years of age at the time of enrolment;
• Subjects must be free of obvious health problems;
• Not pregnant and having no plan for pregnancy;

Exclusion Criteria:

• Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
• Previous vaccination against HPV;
• Having severe allergic history or other immunodeficiency;
• Chemotherapy and other immunosuppressive agents using;