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A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women


Phase 4
16 Years
26 Years
Open (Enrolling)
Female
Cervical Cancer, Cervical Intraepithelial Neoplasia, Adenocarcinoma in Situ

Thank you

Trial Information

A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women


Inclusion Criteria:



- Healthy Japanese females

- Not pregnant at Screening and agree to use effective contraception through Month 7 of
the study

- Lifetime history of 0 to 4 male or female sexual partners

- No oral temperature ≥37.5 centigrade within 24 hours prior to injection

Exclusion Criteria:

- Received a marketed HPV vaccine

- Prior abnormal papanicolaou smear (PAP)or biopsy showing CIN

- Known history of positive test for HPV

- Known history of genital warts

- Received immune globulin or blood products within 6 months prior to first injection
or plan to receive any through Month 7 of the study

- History of splenectomy, known immune disorders, or receiving immunosuppressives

- Immunocompromised or diagnosed as having human immunodeficiency virus

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Combined incidence of CIN 2/3 or worse related to HPV type 6, 11, 16, or 18

Outcome Description:

Pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, AND HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block

Outcome Time Frame:

Up to Month 48 postvaccination

Safety Issue:

No

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

V501-110

NCT ID:

NCT01544478

Start Date:

November 2011

Completion Date:

May 2016

Related Keywords:

  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia
  • Adenocarcinoma in Situ
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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