Trial Information
A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years
Inclusion Criteria:
- Written informed consent from the subject prior to enrolment;
- Female between, and including, 18 and 25 years of age at the time of enrolment;
- Subjects must be free of obvious health problems;
- Not pregnant and having no plan for pregnancy;
Exclusion Criteria:
- Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month
0-7);
- Previous vaccination against HPV;
- Having severe allergic history or other immunodeficiency;
- Chemotherapy and other immunosuppressive agents using;
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody
Outcome Description:
To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.
Outcome Time Frame:
7 months
Safety Issue:
No
Principal Investigator
Jun Zhang, Master
Investigator Role:
Study Chair
Investigator Affiliation:
Xiamen University
Authority:
China: Food and Drug Administration
Study ID:
HPV-PRO-002
NCT ID:
NCT01356823
Start Date:
March 2011
Completion Date:
December 2011
Related Keywords:
- Cervical Intraepithelial Neoplasia
- Cervical Cancer
- Human Papilloma Virus 16
- Human Papilloma Virus 18
- vaccine
- Cervical Intraepithelial Neoplasia
- cervical Cancer
- Neoplasms
- Uterine Cervical Neoplasms
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ