ong-term follow-up: A long-term, open, follow-up of the immunogenicity and safety of the vaccine in healthy female subjects vaccinated either pre- or post-menarche in the HPV-012 study. Primary: A phase III, double-blind, randomized study to assess the consistency of the immunogenicity of three consecutive production lots of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in healthy female subjects aged 10 – 25 years. - HPV-012, Ext HPV-012 Mth 18, Ext HPV-012 Mth 24, Ext HPV-012 Mth 36, Ext HPV-012 Mth 48

Phase 1

• Conditions: For active immunization of women from the age of 10 years onwards to prevent persistent HPV-16 and HPV-18 infection and HPV-16 and HPV-18 associated cervical neoplasia.

• Registration Number: EUCTR2004-001173-26-DK
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

Long-term follow-up:
- A female who enrolled in the HPV-012 study in Denmark, Estonia and Finland, received three doses of vaccine and completed Visit 4 (Month 7).
- Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative (LAR) and, in addition, the subject must sign and personally date a written informed assent).

? Subjects who the investigator believes that they and/or their parents/legally acceptable representatives can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
? A female between, and including, 10 and 25 years of age at the time of the first vaccination.
? Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject should sign and personally date a written informed assent).
? Free of obvious health problems as established by medical history and clinical examination before entering into the study.
? Subjects must have a negative urine pregnancy test.
? Subject must be of non-childbearing potential, e.g. surgically sterilized, 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 adequate contraceptive precautions (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 vaccination 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 are of childbearing potential must agree to follow the same precautions.
? Has had no more than six lifetime sexual partners prior to enrolment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements.
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

Long-term follow-up:
•Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
•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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. (For corticosteroids, this will mean prednisone, or equivalent,
greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.

? 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.
? Pregnant or breastfeeding.
? A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose (i.e. up to Month 8).
? Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or planned administration during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ? 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 after the first dose of vaccine. Administration of routine vaccines such as meningococcal, hepatitis A or B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing 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 MPL® or AS04 adjuvant (no vaccines currently licensed contain these).
? Previous vaccination against HPV.
? 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.
? 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-grade febrile illness, i.e. oral/axillary temperature

Study & Design

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