A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alternative dosing schedule at, 0, 1 and 12 months as compared to the standard dosing schedule at 0, 1 and 6 months in young healthy female subjects aged 15-25 years. - Immunogenicity and Safety Study of GSK Biologicals...

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-003256-11-IT
• Date of registration: 22/11/2007
• Prospective Registration: No
• Primary sponsor: GLAXO SMITHKLINE
• Public title: A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alternative dosing schedule at, 0, 1 and 12 months as compared to the standard dosing schedule at 0, 1 and 6 months in young healthy female subjects aged 15-25 years. - Immunogenicity and Safety Study of GSK Biologicals...
• Scientific title: A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alternative dosing schedule at, 0, 1 and 12 months as compared to the standard dosing schedule at 0, 1 and 6 months in young healthy female subjects aged 15-25 years. - Immunogenicity and Safety Study of GSK Biologicals...
• Date of first enrolment: 02/10/2007
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003256-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: stesso vaccino ad altra schedula

Countries of recruitment

Italy

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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-

Primary Outcome(s)

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.

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.

Secondary ID(s)

BB-IND 7920

109179 (HPV-044 PRI)