NCT01735006

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

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)Human Papillomavirus Bivalent Vaccine in Healthy Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,372 (actual)
• Sponsor: Xiamen University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Intraepithelial Neoplasia
• Cervical Cancer
• Vaginal Intraepithelial Neoplasia
• Vulvar Intraepithelial Neoplasia
• Persistent Infection

Interventions

Type	Name	Description
BIOLOGICAL	HPV Vaccine	3 doses at month 0,1 and 6
BIOLOGICAL	HEV vaccine	3 doses at month 0,1 and 6

Timeline

• Start date: 2012-11-22
• Primary completion: 2019-08-01
• Completion: 2019-10-18
• First posted: 2012-11-28
• Last updated: 2020-02-24

Locations

1 site across 1 country: China