In female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions caused by oncogenic human papillomaviruses (HPV).
Conditions
Interventions
Product Name: Prophylactic HPV-16/-18 L1 VLP vaccine adjuvanted with AS04
Product Code: HPV-16/-18 L1 VLP AS04 vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Human papillom
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 and their parents/legally acceptable representatives (LAR) can, and will, comply with the requirements of the protocol should be enrolled in the study. • A female between, and including, 10 and 18 years of age at the time of the first vaccination. • Written informed consent/assent obtained from the subject, and written informed consent obtained from the subject’s parent/LAR, as appropriate. • Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study. • Previously completed routine childhood vaccinations against diphtheria, tetanus, pertussis and poliomyelitis diseases, according to the recommended vaccination schedule at the time. • Subjects must have a negative urine pregnancy test. • Subject must be of non-childbearing potential i.e., have a current tubal ligation, hysterectomy, ovariectomy, or be pre-menarcheal; or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and must agree to 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) 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(s) within 30 days preceding the first dose of study 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 within six months prior to the first vaccine dose. • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine(s). • A woman 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. • Administration of a diphtheria, tetanus, pertussis (DTP) vaccine, diphtheria-tetanus (dT) booster or dTpa vaccine within the previous five years. • Administration of a pre-school booster of OPV or IPV vaccine (4 or 5th dose) within the previous five years. • Hypersensitivity to latex (found in syringe-tip cap and plunger). • Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, or thrombocytopenia, 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 vaccine (e.g. aluminium, MPL, neomycin, polymyxin, polysorbate 80 etc.) or following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine. • History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause. • Temperature of >40°C within 48 hours of receipt of a prior dose of DTP vaccine (DTPw and/or DTPa), not due to another identifiable cause. • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of receipt of a prior dose of DTP vaccine (DTPw and/or DTPa). • Seizures with or without fever within three days of a prior dose of DTP vaccine (DTPw and/or DTPa). • Persistent, inconsolable crying lasting >3 hours, occurring within 48 hours of a prior dose of DTP vaccine (DTPw and/or DTPa). • Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years. • Known exposure to diphtheria or household exposure to pertussis within 30 days before vaccination with dTpa-IPV. • Diphtheria and/or tetanus and/or pertussis and/or polio diagnosed within 30 days before vaccination with dTpa-IPV. • Presence of a contra-indication to vaccination according to the product leaflet of the commercially available dTpa-IPV vaccine. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and ph
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate non-inferiority of the dTpa-IPV immune response at Month 1 when dTpa-IPV is co-administered with HPV-16/18 L1 AS04 vaccine at Month 0 compared to when dTpa-IPV is administered alone at Month 0.;Secondary Objective: •To demonstrate non-inferiority of the HPV immune response when HPV is co-administered with dTpa-IPV at Month 0 compared to HPV alone. •To evaluate in all HPV vaccine recipients the immune response against HPV-16 and HPV-18 one month after the first dose of HPV vaccine. •To evaluate in all dTpa-IPV vaccine recipients the immune response against anti-D, anti-T, anti-PT, anti-PRN, anti-FHA, anti-Polio type 1, anti-Polio type 2 and anti-Polio type 3 one month after administration of dTpa-IPV. •To evaluate in all vaccine groups the incidence and intensity of solicited local and general symptoms reported during the 7-day period, and unsolicited adverse events reported during the 30-day period, following vaccination. •To assess the safety of the study vaccine with respect to the nature, intensity and relationship to vaccination of serious adverse events, and the occurrence of new onset chronic diseases and other medically significant conditions, in all groups throughout the study period.;Primary end point(s): • Percentage of subjects with anti-D and anti-T antibody titres >0.1 IU/mL before and one month after vaccination with dTpa-IPV in all dTpa-IPV vaccine recipients. • Anti-PT, anti-PRN and anti-FHA GMTs, before and one month after vaccination with dTpa-IPV in all dTpa-IPV vaccine recipients. • Percentage of subjects with anti-Polio type 1, anti-Polio type 2 and anti-Polio type 3 >8 before and one month after vaccination with dTpa-IPV in all Tdap-IPV vaccine recipients. | — |
Countries
France, Germany, Spain
Outcome results
None listed