Estudio en fase III, doble ciego, aleatorizado, controlado, multicéntrico para evaluar la eficacia de la vacuna HPV-16/18 VLP/AS04 de GlaxoSmithKline Biologicals comparada con la vacuna antihepatitis A como control en la prevención de la infección cervical persistente por el HPV-16 o HPV-18 y del cáncer de cérvix, administrada por vía intramuscular conforme a la pauta de vacunación 0, 1 y 6 meses, en mujeres sanas entre 15 y 25 añosA phase III, double-blind, randomized, controlled study to evaluate the efficacy of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine compared to hepatitis A vaccines as control in prevention of persistent HPV-16 or HPV-18 cervical infection and cervical neoplasia, administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 15 – 25 years or age. - HPV-008

Phase 1

• Conditions: cervical cancer => study is conducted in healthy female

• Registration Number: EUCTR2004-001325-14-ES
• Lead Sponsor: GlaxoSmithKline SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-11-26
• Study Start: 2010-04-15
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 18644

Inclusion Criteria

- Female subjects 15 – 25 years of age who have a negative urine pregnancy test at the time of the first vaccination. (If they are of childbearing potential at the time of study entry, they must be abstinent or must be using an effective method of birth control.)
- No more than 6 lifetime sexual partners prior enolment
- Subject must have intact cervix
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy
- Planning to become pregnant or planning to discontinue contraceptive during he first 9 months of the study.
- Previous administration of monophosphoryl lipid A (MPL) or AS04 adjuvant (no vaccines currently licensed contain these).
- 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease (no laboratory testing required).
- Previous vaccination against human papillomavirus (HPV).
- History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
- Planned administration/administration of a vaccine (except Meningococcal, Hepatitis B, Inactivated Influenza, and Diptheria/Tetanus) not foreseen by the study protocol within 30 days before and after the administration of each dose of vaccine.
- Planned administration/administration of routine vaccines such as Meningococcal, Hepatitis B, Inactivated Influenza, and Diphtheria/Tetanus and/or Diphtheria/Tetanus-containing vaccine within 8 days before and 30 days after the administration of each vaccine.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines, e.g. MPL, AS04, Hepatitis A antigen, 2-phenoxyethanol or neomycin.
- Hypersensitivity to latex (found in syringe-tip cap and plunger).
- 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 such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease.
- 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. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Enrollment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C (99.5°F).
- 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 investigators medical judgement.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified