Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine (NCT01735006) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine
China7,372 participantsStarted 2012-11-22
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Female subjects between, and including, 18 and 45 years of age at the first vaccination;
✓. Healthy subjects as established by medical history and history-oriented clinical examination;
✓. Be able to understand and comply with the request of the protocol;
✓. Without acute cervicitis;
✓. Not pregnant;
✓. Have intact cervix.
Exclusion criteria
✕. Use of any investigational or non-registered product (drug or vaccine)within 30 days preceding the first vaccination, or plan to use during the study period;
✕. Are using immunosuppressants;
✕. Administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period;
✕
What they're measuring
1
Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection
Timeframe: expected 5-6 years
2
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition)