Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Immunogenicity Levels in Women With HPV Vaccine in Mexico
Brief Summary: In September 2009 the National Vaccination Council approved the policy for anti-HPV vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the following justification:

* Antibody induction due to the vaccine is greater than that produced by natural exposure to the virus
* Immune response in girls 9 to 11 years of age is similar to the response obtained after three doses in women 16 to 26 years of age
* The third dose will be administered at the time when maximum protection is required, near the onset of sexual activity Thus the National Institute of Public Health was commissioned to monitor anti-HPV antibody levels in women who received the anti-HPV vaccine to determine non-inferiority of the extended scheme in 9-year-old girls compared with the traditional scheme of 3 doses in women 18 to 24 years of age. To this end, a sentinel cohort will be formed to evaluate immunogenicity levels in 3 age groups, and stratified by vaccine type. The hypothesis is that in 9-year-old girls who are administered the amplified HPV vaccination scheme (0-6-60) show immunogenicity levels that are not lower than those of adult women who have been administered the traditional scheme (0-1/2-6).

The main objectives are to monitor the levels of immunity induced by vaccination against HPV with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60 months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent and quadrivalent vaccines in the third dose of extended scheme. The study design is to create a sentinel cohort of women vaccinated against HPV in the following comparison groups:

* Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
* Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
* Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
* Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
* Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
* Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
* Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
* Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
* Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
* To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15 years, who have not been vaccinated against HPV, will be invited , in order to make the monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post dose 0 in vaccinated groups


Options:
A: DISEASE CHARACTERISTICS:

•Healthy participants

* Deemed to be in good general health by history and physical examination

  •Resident of Guanacaste Province of Costa Rica and surrounding areas
* Must remain a resident for ≥ 6 months after the first study vaccination

PATIENT CHARACTERISTICS:

Age

* 18 to 25

Performance status

•Not specified

Life expectancy

•Not specified

Hematopoietic

•Not specified

Hepatic

* No history of chronic hepatitis requiring treatment
* No acute or chronic clinically significant hepatic function abnormality by physical examination or laboratory findings
* No known history of hepatitis A infection

Renal

* No history of kidney disease requiring treatment
* No acute or chronic clinically significant kidney function abnormality by physical examination or laboratory findings

Cardiovascular

* No acute or chronic clinically significant cardiovascular function abnormality by physical examination or laboratory findings Pulmonary
* No acute or chronic clinically significant pulmonary function abnormality by physical examination or laboratory findings Immunology
* No history of allergic disease
* No history of autoimmune disorder requiring treatment
* No history of allergic reaction (e.g., difficulty breathing) to any vaccine
* No suspected allergy or reaction likely to be exacerbated by a component of the study vaccines (e.g., 2-phenoxyethanol or neomycin)
* No hypersensitivity to latex
* No diagnosis or suspicion of any immunodeficient condition by medical history or physical examination Other
* Not pregnant or nursing

  ◦No delivery within the past 3 months
* Negative pregnancy test
* Fertile patients must use effective contraception for 30 days before, during, and for 60 days after completion of study treatment
* Able to speak or understand Spanish
* Mentally competent
* Able to undergo pelvic exam (i.e., no heavy bleeding \[menstruation or otherwise\] or heavy vaginal discharge)
* No history of cancer requiring treatment
* No history of diabetes requiring treatment
* No history of other chronic conditions requiring treatment
* No acute or chronic clinically significant neurologic function abnormality by physical examination or laboratory findings
* No other acute disease
* No fever ≥ 37.5º C

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 6 months since prior chronic administration (i.e., \> 14 days) of immune-modulating drugs
* More than 90 days since prior immunoglobulins
* More than 30 days since prior and no other concurrent investigational or non-registered vaccines
* More than 30 days since prior registered vaccines
* More than 8 days since prior routine meningococcal, hepatitis B, influenza, or diphtheria/tetanus vaccine
* No prior vaccination against hepatitis A
* No prior vaccination against human papillomavirus
* No prior monophosphoryl lipid A or AS04 adjuvant

Chemotherapy

•Not specified

Endocrine therapy

* More than 6 months since prior chronic administration (i.e., \> 14 days) of corticosteroids (e.g., ≥ 0.5 mg/kg/day of prednisone or equivalent)
* Concurrent inhaled or topical steroids allowed

Radiotherapy

•Not specified

Surgery

•No prior hysterectomy

Other

* More than 6 months since prior chronic administration (i.e., \> 14 days) of immunosuppressants
* More than 30 days since prior and no other concurrent investigational or non-registered drugs
B: 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.
C: 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).
D: Inclusion Criteria:

* • Women 18 to 24 years of age who agree to participate by signing an informed consent form prior to recruitment.

  * Girls 9 and 10 years of age whose father/mother/guardian signs the informed consent form to participate in the study.

Exclusion Criteria:

* • Prior administration of an anti-HPV vaccine

  * Pregnant women or women planning to get pregnant in the next 8 months.
  * Auto-immune diseases
  * Women with a history of Guillain Barré syndrome.
  * Prior administration of immunoglobulins and/or any blood product in the past 6 months before the study's first vaccine dose.

Answer: D