For active immunization of females from the age of 10 years onwards to prevent incident and persistent infections, cytological abnormalities and cervical neoplasia (CIN), CIN 1 and pre-cancerous lesions (CIN 2 and CIN 3), caused by oncogenic human papillomavirus (HPV) types 16 and 18. MedDRA version: 6.1 Level: HLT Classification code 10029109
Conditions
Interventions
Product Name: HPV-16/18 L1 VLP AS04
Product Code: GSK580299
Pharmaceutical Form: Suspension for injection
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 40-
Sponsors
GLAXO SMITHKLINE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) 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 15 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 the subject?s parents/legally acceptable representative (LAR), and written informed assent must be obtained from the subject. · Healthy subjects as established by medical history and/or clinical examination before entering into the study. · Subject must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative urine pregnancy test and continue such precautions for 2 months after completion of the vaccination series. · Subject who had no more than 6 lifetime sexual partners prior to enrolment. 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: 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, ³ 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. Planned administration/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 patient is outside of 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). · Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the immunogenicity of GSK Biologicals? HPV-16/18 L1 VLP AS04 vaccine administered according to an alternative schedule of 0, 1, 12 months is non-inferior to that of the vaccine administered according to a standard schedule of 0, 1, 6 months one month after the third dose.;Secondary Objective: To assess the safety and reactogenicity of the HPV-16/18 L1 VLP AS04 vaccine in both groups after each dose. · To assess the immunogenicity one month after the administration of the second dose of HPV-16/18 L1 VLP AS04 vaccine in both groups. · To evaluate compliance with completion of the vaccination course in both groups.;Primary end point(s): Anti-HPV-16/18 seroconversion rates one month after the third dose of HPV-16/18 L1 VLP AS04 vaccine in both groups. · Anti-HPV-16/18 antibody titres one month after the third dose of HPV-16/18 L1 VLP AS04 vaccine in both groups. | — |
Countries
Italy
Outcome results
None listed