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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


Phase 3
18 Years
45 Years
Open (Enrolling)
Female
Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection

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Trial Information

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


Inclusion Criteria:



1. Female subjects between, and including, 18 and 45 years of age at the first
vaccination;

2. Healthy subjects as established by medical history and history-oriented clinical
examination;

3. Be able to understand and comply with the request of the protocol;

4. Without acute cervicitis;

5. Not pregnant;

6. Have intact cervix.

Exclusion Criteria:

1. 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;

2. Are using immunosuppressants;

3. Administration of immunoglobulin and/or any blood products within the three months
preceding the first vaccination or planned administration during the study period;

4. Vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the
enrollment;

5. Fever;

6. Concurrently participating another clinical trial;

7. Has received vaccines against HPV 16/18 ;

8. Immunodeficient;

9. History of allergic disease;

10. Serious medical disorders;

11. Blood coagulation disorders;

12. Epilepsy;

13. Unable to comply with protocol due to the mental illness;

14. Visible Condyloma;

15. Pregnant or breast-feeding women;

16. vergins;

17. Have more than 4 sexual partners.

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:

Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection

Outcome Time Frame:

expected 5-6 years

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-003

NCT ID:

NCT01735006

Start Date:

November 2012

Completion Date:

September 2018

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Vaginal Intraepithelial Neoplasia
  • Vulvar Intraepithelial Neoplasia
  • Persistent Infection
  • Human Papillomavirus 16
  • Human Papillomavirus 18
  • vaccine
  • Cervical Intraepithelial Neoplasia
  • cervical Cancer
  • Vaginal intraepithelial neoplasia
  • Vulvar intraepithelial neoplasia
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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