NCT01021904

Brief Summary

In a hospital-based multi-center study in China, HPV 16 was found to be the predominant type (72.9%) in cervical cancer, followed by HPV 18(8.0%) which indicated that if the HPV prophylactic vaccine are wisely applied in China, about 80% of cervical cancer can be prevented.The reported prevalence of HPV in the female population in China was about 13.2%, with women in the study between ages 15-55. HPV prevalence peaks in young adults (ages 20-24:15.5%) and pre-menopausal women (ages 45-49:15%) and this suggests an underestimation of cervical cancer burden in China. So far, there is no nation wide organized screening program in China, nor is the vaccine available for girls innocent to HPV infection. This study aims to vaccinate the daughters (aged between 13-15 yrs) living in the selected study areas thus to evaluate how cervical cancer and other HPV related diseases can be curbed through primary and secondary prevention(in company to screening the mothers aged 35-54 yrs) and to develop a China specific model for cervical cancer prevention through HPV vaccination and HPV DNA test (careHPV).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 30, 2009

Status Verified

November 1, 2009

Enrollment Period

4 years

First QC Date

November 27, 2009

Last Update Submit

November 27, 2009

Conditions

HPV InfectionsPrecancerous Disease of the CervixCervical CancerHPV Related Diseases

Keywords

Primary preventionHPV VaccinationHPV InfectionCervical CancerHPV Related Diseases

Outcome Measures

Primary Outcomes (1)

  • The quadrivalent HPV vaccine can prevent HPV naive girls at baseline from being infected at least on a five year follow-up and longer.

    5 years

Secondary Outcomes (3)

  • Knowledge of HPV and the link between HPV and cervical cancer

    5 years

  • Attitudes towards HPV vaccine

    5 years

  • Attitudes towards sex and the proper age of sexual debut;

    5 years

Interventions

Gardasil (VLP, HPV Quadrivalent prophylactic vaccine)BIOLOGICAL

0.5cc I/M Site deltoid Lt Rt 3-dose regimen: 0, 2, 6 months

Eligibility Criteria

Age13 Years - 15 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Long term residence in the selected study areas (at least more than 5 years from the beginning of the study)
  • aged between 13-15 yrs
  • With complete cervix
  • Not sexually active
  • Physically competent to undergo vaccination
  • With ability to provide informed consent

You may not qualify if:

  • Short term residence (less than 5 years from the beginning of the study)
  • Dose not have a cervix
  • Physically incompetent to undergo vaccination
  • With no ability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Munoz N. Human papillomavirus and cancer: the epidemiological evidence. J Clin Virol. 2000 Oct;19(1-2):1-5. doi: 10.1016/s1386-6532(00)00125-6.

    PMID: 11091143BACKGROUND

  • Bosch FX, Lorincz A, Munoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. doi: 10.1136/jcp.55.4.244.

    PMID: 11919208BACKGROUND

  • Trottier H, Franco EL. The epidemiology of genital human papillomavirus infection. Vaccine. 2006 Mar 30;24 Suppl 1:S1-15. doi: 10.1016/j.vaccine.2005.09.054.

    PMID: 16406226BACKGROUND

  • Schiffman M, Castle PE. Human papillomavirus: epidemiology and public health. Arch Pathol Lab Med. 2003 Aug;127(8):930-4. doi: 10.5858/2003-127-930-HPEAPH.

    PMID: 12873163BACKGROUND

  • Franco EL, Harper DM. Vaccination against human papillomavirus infection: a new paradigm in cervical cancer control. Vaccine. 2005 Mar 18;23(17-18):2388-94. doi: 10.1016/j.vaccine.2005.01.016.

    PMID: 15755633BACKGROUND

  • Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. doi: 10.1056/NEJMoa021641.

    PMID: 12571259BACKGROUND

  • Cox JT. Epidemiology and natural history of HPV. J Fam Pract. 2006 Nov;Suppl:3-9.

    PMID: 17366752BACKGROUND

  • Padel AF, Venning VA, Evans MF, Quantrill AM, Fleming KA. Human papillomaviruses in anogenital warts in children: typing by in situ hybridisation. BMJ. 1990 Jun 9;300(6738):1491-4. doi: 10.1136/bmj.300.6738.1491.

    PMID: 2164854BACKGROUND

  • Sugase M, Moriyama S, Matsukura T. Human papillomavirus in exophytic condylomatous lesions on different female genital regions. J Med Virol. 1991 May;34(1):1-6. doi: 10.1002/jmv.1890340102.

    PMID: 1653304BACKGROUND

  • Qiao YL, Sellors JW, Eder PS, Bao YP, Lim JM, Zhao FH, Weigl B, Zhang WH, Peck RB, Li L, Chen F, Pan QJ, Lorincz AT. A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China. Lancet Oncol. 2008 Oct;9(10):929-36. doi: 10.1016/S1470-2045(08)70210-9. Epub 2008 Sep 19.

    PMID: 18805733BACKGROUND

MeSH Terms

Conditions

Papillomavirus InfectionsUterine Cervical Neoplasms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Officials

  • You-lin Qiao, M.D. Ph.D.

    Cancer Hospital/Institute, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

You-Lin Qiao, Ph.D

CONTACT

+86-10-8778-8489Qiaoy@cicams.ac.cn

Jing Li, M.D. M.Sc

CONTACT

86-10-8778-8942leej@cicams.ac.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 27, 2009

First Posted

November 30, 2009

Study Start

June 1, 2010

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

November 30, 2009

Record last verified: 2009-11