A Phase 3 interventional study of HPV Vaccine and HEV vaccine in Cervical Intraepithelial Neoplasia, Cervical Cancer and Vaginal Intraepithelial Neoplasia, sponsored by Xiamen University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Xiamen University · Phase 3, Interventional, and Prevention
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.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
This study's enrollment of 7,372 is above the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Xiamen University is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant
Biological: HPV Vaccine
commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant
Biological: HEV vaccine
3 doses at month 0,1 and 6
3 doses at month 0,1 and 6
Also known as: Hecolin
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
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
Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types
Histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) detected within the lesional component of the tissue specimen (by PCR).
Time frame: expected 5-6 years
Ran from Nov 2012 to primary completion in Aug 2019, 80 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xiamen University