Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Double-blind, Randomized, Controlled Study to Evaluate Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly (0, 1, 6 Month Schedule) in Healthy Females Aged 18 - 35 Years
Brief Summary: Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Inclusion criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A female of Chinese origin, residing in Hong Kong aged between, and including, 18 and 35 years at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects must have a negative urine pregnancy test.
* Subjects of childbearing potential at the time of study entry must be abstinent or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study/ control vaccine within 30 days preceding the first dose of study/ control vaccine, or planned use during the study period.
* Pregnant or breastfeeding.
* Planning to become pregnant or likely to become pregnant.
* 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. Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
* Previous administration of components of the investigational vaccine.
* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
* 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/ control vaccines.
* Hypersensitivity to latex.
* Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
* History of chronic condition(s) requiring treatment.
* Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/ control vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
* Acute disease at the time of enrolment.
B: Inclusion Criteria:

* Female between and including 15 and 25 years of age at the time of screening (must not have reached 26th birthday)
* Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must also be obtained from a parent or legal guardian of the subject)
* Free of obvious health problems, as established by medical history and a directed physical examination
* No more than 6 lifetime sexual partners prior to enrolment
* Intact uterus
* Subject must be of non-childbearing potential, i.e., either surgically sterilised or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination, have a negative urine pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series
* For subjects not enrolled in the HPV epidemiology study (999910/106) and for subjects completing the study (999910/106) \>90 days prior to enrolment in the present study: agreement to complete both entrance and exit study questionnaires concerning general personal information, and sexual, contraceptive, reproductive and other gynaecological medical history
* For subjects previously enrolled in the HPV epidemiology study (and who completed the study and an entrance questionnaire) ≤ 90 days prior to enrolment in the present study: agreement to complete the exit questionnaire only.
* Normal cervical cytology (Pap smear) at screening, using the Cytyc ThinPrep® Pap Test. A normal Pap smear must also be adequate for interpretation, including the presence of endocervical cells; a Pap smear that is normal but inadequate for interpretation must be repeated as part of the protocol
* Seronegative for HPV-16 and HPV-18 antibody by ELISA at screening
* HPV DNA PCR negative for high-risk HPV types by PCR at screening. Genotyping will be specified using a reverse line probe assay specific for the detection of high-risk HPV types such as HPV-16, HPV-18 and HPV-16/18-related phylogenetic types

Exclusion Criteria:

* Pregnant or lactating female
* Female planning to become pregnant during the first eight months of the study (months 0-8)
* Abnormal vaginal discharge at the time of entry (once these subjects have received therapy to eradicate any discharge they will be eligible to participate in study)
* Previous administration of any components of the investigational vaccine
* Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period
* Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine. Administration of routine Meningococcal, Hepatitis A, Hepatitis B, Influenza, and Diphtheria/Tetanus vaccine up to 8 days before the first dose of study vaccine is allowed
* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
* Receiving or expecting therapy for external or internal condylomata. Subjects with external condylomata not requiring therapy are eligible to participate in the study
* Genital herpes disease involving the cervix or characterized (on examination or by history) by extensive external lesions. Subjects with a history of recurrent genital herpes disease characterized by limited external lesions are eligible to participate in the study
* History of an abnormal cervical cytology (Pap smear) test (other than a single prior report of ASCUS with a subsequent normal report)
* Treatment for cervical disease by ablative therapy (cryotherapy or laser ablation) or excisional therapy (laser cone biopsy, loop excision, cold-knife conization)
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* A family history of congenital or hereditary immunodeficiency
* Major congenital defects or serious chronic illness
* History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
* Acute disease at the time of enrolment.
* Oral temperature ≥99.5°F (≥37.5°C) / axillary temperature ≥99.5°F (37.5°C) / rectal temperature ≥100.4°F (≥38.0°C) / tympanic temperature on oral setting ≥99.5°F (37.5°C) / tympanic temperature on rectal setting ≥100.4°F (≥38.0°C)
* History of chronic alcohol consumption and/or intravenous drug abuse within the past 2 years
* Known or suspected allergy to any vaccine component
* Hepatomegaly, right upper quadrant abdominal pain or tenderness
C: Inclusion Criteria:

* Subjects who the investigator believes that they and their parents/legally acceptable representatives can, and will, comply with the requirements of the protocol should be enrolled in the study.
* A female between, and including, 10 and 18 years of age at the time of the first vaccination.
* Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below legal age of consent, written informed consent obtained from the subject's parent/LAR, and written informed assent must be obtained from the subject.
* Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
* Previously completed routine childhood vaccinations according to the recommended vaccination schedule at the time.
* Subjects must have a negative urine pregnancy test.
* Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception 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. Subjects who reach menarche during the study, and therefore become of childbearing potential, must agree to follow the same precautions.

Exclusion Criteria:

* 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 (up to Month 12/13).
* 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).
* 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 each dose of vaccine(s). Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
* A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
* Pregnant or breastfeeding women.
* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
* Previous administration of components of the investigational vaccine
* Administration of a diphtheria, tetanus, pertussis (DTP) vaccine, diphtheria-tetanus (Td) booster or dTpa vaccine within the previous five years.
* Administration of a pre-school booster of Oral Polio Vaccine (OPV) or Inactivated Polio Virus (IPV) vaccine (4 or 5th dose) within the previous five years.
* Hypersensitivity to latex.
* Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality or thrombocytopenia, as determined by previous physical examination or laboratory tests.
* Cancer or autoimmune disease under treatment.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
* Temperature of \>=40°C within 48 hours of receipt of a prior dose of DTP vaccine (DTPw and/or DTPa), not due to another identifiable cause.
* Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine (DTPw and/or DTPa).
* Seizures with or without fever within three days of a prior dose of DTP vaccine (Diphtheria, Tetanus, whole cell Pertussis vaccine DTPw and/or Diphtheria, Tetanus, acellular Pertussis vaccine DTPa).
* Persistent, inconsolable crying lasting \>=3 hours, occurring within 48 hours of a prior dose of DTP vaccine (DTPw and/or DTPa).
* Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years.
* Known exposure to diphtheria or household exposure to pertussis within 30 days before (i.e., Day 0-29) vaccination with Diphtheria, Tetanus, acellular Pertussis and inactivated polio virus vaccine (dTpa-IPV).
* Diphtheria and/or tetanus and/or pertussis and/or polio diagnosed within 30 days before (i.e., Day 0-29) vaccination with dTpa-IPV.
* Presence of a contra-indication to vaccination according to the product leaflet of the commercially available dTpa-IPV vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. Enrolment will be postponed until the subject is outside the specified window.
D: Inclusion Criteria:

* HIV positive subjects.
* Age above 18 at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Subjects whom the investigator believes can and will comply with the requirements of the protocol.
* If currently on antiretroviral therapy (ART), subjects must be compliant to triple therapy (highly active ART) and have undetectable viral load for a period of six months prior to study entry.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject has a negative pregnancy test at screening and on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period.

Exclusion Criteria:

* Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 12).
* Pregnant or breastfeeding female.
* Previous enrollment in the study.
* Subjects whom the investigator believes cannot and/or will not comply with the requirements of the protocol (i.e. because of abuse of drugs or alcohol, dementia or given medical, psychiatric, social or work related conditions).
* Chronic administration of immunosuppressive drugs
* Cancer or autoimmune disease
* Previous allergic reaction to vaccination
* Known allergy towards on or more components of either of the test drugs.

Answer: A