AzTrials
AzTrials

HPV InfectionsPhase 4NCT01021904

Primary and Secondary Prevention of Human Papillomavirus (HPV) Disease in China

A Phase 4 study testing Gardasil (VLP, HPV Quadrivalent prophylactic vaccine) in people with HPV Infections and Precancerous Disease of the Cervix, run by Chinese Academy of Medical Sciences.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 13 to 15 years, women onlyHealthy volunteers can take part
What is being tested?
Gardasil (VLP, HPV Quadrivalent prophylactic vaccine)
Type of treatment
Vaccines
How many people
6,200 participants
Where
No sites listed yet
Study dates
Jun 2010to Dec 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 15 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

You-Lin Qiao, Ph.D contact

+86-10-8778-8489

Qiaoy@cicams.ac.cn

Jing Li, M.D. M.Sc contact

86-10-8778-8942

leej@cicams.ac.cn

About this study

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).

Read the detailed description

Selection of Vaccination age group

-It is well acknowledged that preadolescent or adolescent girls before their sexual debut will benefit the most from HPV vaccination. According to our previous study conducted in year 2007, the median age of sexual debut in Xinjiang was 17 years old (95% CI: 14-21). Data on the age of sexual debut in the other two identified regions is not available and we made an approximate estimation according to our data previously collected from other parts of China.From these data, we don't see an obvious time trend of sexual debut age from other parts of China and the majority of girls became sexually active after 15 years old. We thus suggest coverage of 13-15 years old girls for HPV vaccination in our identified regions.

Goal of this Program

-The purpose of this program is to implement and evaluate what it takes to establish and operate a public health program on cervical cancer prevention by vaccination and early detection treatment program in resource restricted selected autonomous regions of China. The learnings on how to implement such projects and the costing of the interventions and program will be useful for national policy planners and regional authorities when they consider future health priorities and allocation of resources.

Objectives

The objectives of the pilot program are to:

  1. Develop a communication and education program on cervical cancer for families in the target area and try to deliver the message of 'Vaccinate the daughters and screen the mothers' to curb cervical cancer.
  2. Develop a China specific model for cervical cancer prevention through HPV vaccination and HPV DNA test ( careHPV).
  3. Capacitate the health facilities in the selected counties in each region to conduct HPV vaccination, screen for cervical cancer and treat precancerous lesions and cervical cancer.
  4. Develop a referral system for advanced cases of cervical cancer that cannot be treated at lower level facilities
  5. Develop training guidelines and supportive management systems for all levels of the health care system and cost all interventions for policy purposes.
Being tested
Gardasil (VLP, HPV Quadrivalent prophylactic vaccine)
Keywords
Primary prevention, HPV Vaccination, HPV Infection, Cervical Cancer, HPV Related Diseases
Medical subject headings
Papillomavirus Infections, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gardasil (VLP, HPV Quadrivalent prophylactic vaccine)Biological

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Secondary outcomes (3)

  1. Knowledge of HPV and the link between HPV and cervical cancer

    Measured: 5 years

  2. Attitudes towards HPV vaccine

    Measured: 5 years

  3. Attitudes towards sex and the proper age of sexual debut;

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2009 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
6,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01021904
Sponsor's protocol ID
37207
Status last verified
Nov 2009
First submitted
27 Nov 2009
Last updated
30 Nov 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11091143

  • 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.

    PubMed 11919208

  • 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.

    PubMed 16406226

  • 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.

    PubMed 12873163

  • 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.

    PubMed 15755633

  • 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.

    PubMed 12571259

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

    PubMed 17366752

  • 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.

    PubMed 2164854

  • 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.

    PubMed 1653304

  • 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.

    PubMed 18805733

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gardasil (VLP, HPV Quadrivalent prophylactic vaccine) in people with HPV Infections and Precancerous Disease of the Cervix, run by Chinese Academy of Medical Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact You-Lin Qiao, Ph.D (+86-10-8778-8489, Qiaoy@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The quadrivalent HPV vaccine can prevent HPV naive girls at baseline from being infected at least on a five year follow-up and longer. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01021904, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in