To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9-45
SponsorShanghai Bovax Biotechnology Co., Ltd.

About this trial

To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.

Eligibility criteria

Qualifiers

Participants aged 9-45;

Participants aged 18-45 who can provide legal identification,participants aged 9-17 and their guardian can provide legal identification;

Participants and/or their guardian sign an informed consent form;

Axillary temperature less than 37.3 ℃(>14 years old)or less than 37.5℃(≤14 years old)at the time of enrollment;

Disqualifiers

Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV vaccines during the study period;

Plan to participate other clinical trials during the study period,or participated other clinical trials (including vaccine or drug)and received medication or vaccine within 3 months before enrollment ,

History of positive HPV testing (including types not covered by the trial vaccine) among the participants aged 18-45 years old;

History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy in female participants;

Trial design

Treatments tested in this trial

  • Medium dose for 15-HPV vaccine
  • High dose for 15-HPV vaccine
  • Placebo
  • 9-HPV vaccine

Treatment groups

330 Participants
are divided into 4 treatment groups