A study to evaluate safety, immunogenicity and efficacy of GSK Biologicals HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

• Conditions: For active immunization of girls and women from 10 years of age onwards for the prevention of persistent human papillomavirus (HPV) infections and related clinical outcomes (cytological abnormalities and pre-cancerous lesions) caused by oncogenic HPV types 16 and 18.; MedDRA version: 14.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-002546-20-PT
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-16
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 5751

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:
- A woman who the investigator believes that she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- A women of at least 26 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Subject must have intact cervix (e.g. no history of cauterization or surgical treatment involving damage to the transformation zone of the cervix).
Note: A subset of subjects with a previous history of HPV infection/treatment are allowed to enter the study (see Section 5.2.1). For this subset of subjects, the above mentioned inclusion criterion does not apply, and is replaced by:
Subject must have a cervix.
- Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential (e.g. surgically sterilized or one year post-menopausal).
- Subject must be of non-childbearing potential (e.g. surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using an effective method of birth control (i.e. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestogen-only implantable cutaneous hormonal patch or injectable contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam) for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
Are the trial subjects under 18? no
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 5751
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study).
- A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 – 8).
- Use of any investigational or non-registered product (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 (up to Month 84).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, at least 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- 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) the first dose of study vaccine. Planned administration/administration of routine meningococcal, hepatitis A or B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine 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 MPL® or AS04 adjuvant.
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy.
Note: A subset of subjects with a previous history of HPV infection/treatment are allowed to enter the study (see Section 5.2.1). For this subset of subjects, the above mentioned exclusion criterion is not applicable.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no lab testing required).
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine, e.g. aluminium, MPL®.
- Hypersensitivity to latex (found in syringe-tip cap and plunger).
- Known acute or chronic, clinically significant 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.This exclusion criterion should be understood as exclusion of subjects having significant medical conditions (such as cancer, autoimmune diseases) currently under treatment.
- Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study 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. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Enrolment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection with or without low-g

Study & Design

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