Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Infections, Papillomavirus

Treatments

Biological: Aimmugen™

Biological: HPV-16/18 vaccine (Cervarix™)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00316693

104798

Details and patient eligibility

About

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 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.

Full description

The Protocol Posting has been updated to reflect changes as a consequence of an amendment to the protocol. Sections impacted are Official Title of the study and Intervention name.

Enrollment

1,046 patients

Sex

Female

Ages

20 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

Subjects who the investigator/co-investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A Japanese female subject between, and including, 20 and 25 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to enrolment.
Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
Subjects must have a negative urine pregnancy test.
Subjects must be of non-childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Subject must have an intact cervix

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/control within 30 days preceding the first dose of study vaccine/control, or planned use during the study period.
Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to 2 months after the last vaccine dose
previous administration of components of the investigational vaccine
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 the first dose of vaccine. Routine vaccines may be allowed up to 8 days before the first dose of study vaccine.
Previous vaccination against HPV.
History of vaccination against hepatitis A or a known clinical history of hepatitis A disease
Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
History of allergic disease 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.
Cancer or autoimmune disease under treatment.
History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be performed
Acute disease at the time of enrolment.
Oral temperature >= 37.5°C / axillary temperature > 37.5°C.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).