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Contact Information:

Study Location:

GSK Investigational Site
Manchester
M15 6SX


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Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18

Completed

Open to: Female

Age: 15 Years - 25 Years

Medical Conditions

Infections, Papillomavirus


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NOTE: Some 178 centers participate in this study. Given that the recruitment is completed, the researchers have listed one center per country in this website. If required, further details of centers available on request.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2004

Nov 2006

Interventional

Intervention Type : Biological
Intervention Description : Intramuscular injection, 3 doses

Intervention Arm Group : Cervarix Group

Intervention Type : Biological
Intervention Description : Intramuscular injection, 3 doses

Intervention Arm Group : Havrix Group

You can take part if:


Inclusion Criteria: - A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). - A woman between, and including, 15 and 25 years of age at the time of the first vaccination. - Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent). - Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study. - Subject must have a negative urine pregnancy test. - Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series. - Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements. - Subject must have intact cervix. Exclusion Criteria: - Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study. - A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8). - Previous administration of components of the investigational vaccine. - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. - Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. - Previous vaccination against human papillomavirus (HPV). - History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease. - History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test. - Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination. - History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines. - Hypersensitivity to latex. - Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. - History of chronic condition(s) requiring treatment. - Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment will be deferred until the subject is outside of specified window. - Acute disease at the time of enrolment. - Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigator's medical judgement.




You may not be able to take part if:

This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • GSK Investigational Site
    Manchester
    M15 6SX
  • GSK Investigational Site
    Manchester
    M13 9WL
  • GSK Investigational Site
    London
    SW17 0QT
  • GSK Investigational Site
    Waterloo, Liverpool
    L22 0LG
  • GSK Investigational Site
    Aberdeen
    AB25 2ZN
  • GSK Investigational Site
    London
    W1P 1LB


The study is sponsored by GlaxoSmithKline .



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for Trial ID: NCT00122681

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