For the prevention of high grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believes that they and/or their parents/legally acceptable representatives (LARs) 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, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination. •Written informed consent obtained from the subject’s parent/LAR prior to the enrolment. In addition, written informed assent must be obtained from the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study. •Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test. •If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche (begin menstruating) during the study, and therefore become of childbearing potential, must agree to follow the same precautions. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: •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 12). •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 >= 0.5 mg/kg/day, or equivalent. 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) each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine is allowed. •Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). •A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. •Pregnant or breastfeeding women. •Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. •Previous administration of MPL or AS04 adjuvant. •Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period. •History of hepatitis B infection. •Known exposure to hepatitis B within the previous 6 weeks. •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 allergic disease or reactions likely to be exacerbated by any component of the vaccines (e.g. aluminium, yeast, neomycin, formaldehyde, MPL, phenoxyethanol). •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/axillary temperature <37.5°C). •Administration of immunoglobulins and/or any blood products within the three 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate non-inferiority of the hepatitis B immune response at Month 7 when hepatitis B vaccine is co-administered with HPV-16/18 vaccine at Months 0, 1 and 6 (HPV+HepB group) as compared to when hepatitis B vaccine is administered alone at Months 0, 1 and 6 (HepB group). •To demonstrate non-inferiority of the HPV immune response at Month 7 when the HPV-16/18 vaccine is co-administered with hepatitis B vaccine (HPV+HepB group) as compared to when the HPV-16/18 vaccine is administered alone (HPV group).;Secondary Objective: •To evaluate at Month 7 in the HepB vaccine recipients the immune response against hepatitis B. •To evaluate at Month 2 in the HPV vaccine recipients the immune response against HPV-16 and HPV-18. •To evaluate at Month 2 in the HepB vaccine recipients the immune response against hepatitis B. •To evaluate the incidence and intensity of solicited local symptoms reported during the 7-day period following each and any vaccination in all study groups. •To evaluate the incidence, intensity and relationship to vaccination of solicited general symptoms reported during the 7-day period, unsolicited AEs reported during the 30-day period following any vaccination in all study groups. •To assess the safety of the study vaccine with respect to the nature, intensity and relationship to vaccination of SAEs and the occurrence of medically significant conditions in all study groups throughout the study period. ;Primary end point(s): •Anti-HBs seroprotection status at Month 7 in subjects receiving the HepB vaccine. •Anti-HPV-16/18 seroconversion status at Month 7 in subjects receiving the HPV-16/18 vaccine. •Anti-HPV-16/18 antibody titres at Month 7 in subjects receiving the HPV-16/18 vaccine. | — |
Countries
Netherlands, Sweden
Outcome results
None listed