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 L1/AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in healthy female subjects aged 18 – 25 years and to demonstrate non-inferiority of the candidate HPV vaccine manufactured at 600L scale compared with a lower (80L) manufacturing scale. - HPV-016

Phase 1

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

• Registration Number: EUCTR2005-001667-58-LT
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-07
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 798

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•A female between, and including, 18 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 physical 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.
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
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:
•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.
•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, higher than or equal to 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 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.
•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).
•Pregnant or breastfeeding women.
•Previous vaccination against HPV.
•Previous administration of MPL® or AS04 adjuvant.
•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.
•Cancer or autoimmune disease under treatment.
•History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. aluminum, MPL).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature <37.5°C (99.5°F) / axillary temperature <37.5°C (99.5°F)).
•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.
•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).

Study & Design

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