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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


Phase 2
18 Years
25 Years
Open (Enrolling)
Female
Cervical Intraepithelial Neoplasia, Cervical Cancer

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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

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