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Phase 4
13 Years
15 Years
Not Enrolling
HPV Infections, Precancerous Disease of the Cervix, Cervical Cancer, HPV Related Diseases

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Trial Information

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.


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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

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.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

You-lin Qiao, M.D. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Hospital/Institute, Chinese Academy of Medical Sciences


China: Ethics Committee

Study ID:




Start Date:

June 2010

Completion Date:

December 2014

Related Keywords:

  • HPV Infections
  • Precancerous Disease of the Cervix
  • Cervical Cancer
  • HPV Related Diseases
  • Primary prevention
  • HPV Vaccination
  • HPV Infection
  • Cervical Cancer
  • HPV Related Diseases
  • Uterine Cervical Neoplasms