Clinical Trial: Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase III Multicenter, Randomized, Double-Blind, Placebo(Hepatitis E Vaccine)Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant(E.Coli

Brief Summary: This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.

Detailed Summary:
Sponsor: Xiamen University

Current Primary Outcome:

  • Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection [ Time Frame: expected 5-6 years ]
  • Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) [ Time Frame: expected 2-3 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: Within 7 days after each vaccination ]
  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Month 7 ]
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: expected 5-6 years ]
  • number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18 [ Time Frame: expected 5-6 years ]
  • number of subjects Histopathologically-confirmed CIN1+ and/or VIN1+ and/or VaIN1+ associated with HPV-16 and/or -18 cervical infection [ Time Frame: expected 5-6 years ]
  • number of subjects with incidence infection associated with HPV-16 and/or HPV-18 [ Time Frame: expected 2-3 years ]
  • Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 [ Time Frame: month 7 ]


Original Secondary Outcome: Same as current

Information By: Xiamen University

Dates:
Date Received: November 18, 2012
Date Started: November 2012
Date Completion: September 2018
Last Updated: December 30, 2015
Last Verified: December 2015