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.
Conditions
Interventions
Product Name: Prophylactic HPV-16/18 vaccine adjuvanted with AS04
Product Code: HPV-16/18 L1/AS04
Pharmaceutical Form: Suspension for injection
Other descriptive name: HPV-16/18 L1/AS04
Concentration
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: First primary objective: •To demonstrate lot-to-lot consistency in terms of immunogenicity between three consecutive industrial production lots (600L scale) of the HPV-16/18 VLP/AS04 vaccine one month after the third dose (Month 7). Second primary objective: •To demonstrate that the HPV vaccine produced at 600L manufacturing scale is non-inferior in terms of immunogenicity to the HPV vaccine produced at 80L scale one month after the third dose (Month 7).;Secondary Objective: •Evaluation of immunogenicity in terms of seroconversion rates of three industrial scale vaccine production lots (600L scale) one month after the third dose (Month 7). •Evaluation of immunogenicity in terms of GMTs of three industrial scale vaccine production lots (600L scale) one month after the second dose (Month 2). •Evaluation of immunogenicty in terms of seroconversion and GMTs of the vaccine produced at 600L manufacturing scale compared with 80L scale one month after the second dose (Month 2). •To evaluate the safety and reactogenicity of all study vaccines after each dose.;Primary end point(s): •Anti-HPV-16/18 seroconversion and seropositivity rates in subjects receiving the three 600L scale lots of the HPV-16/18 L1/AS04 vaccine assessed by ELISA at Month 7. •Anti-HPV-16/18 seroconversion and seropositivity rates in subjects receiving the 80L scale lot HPV vaccine assessed by ELISA at Month 7. | — |
Countries
Denmark, Lithuania
Outcome results
None listed