Evaluation of the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV vaccine 580299 when administered in healthy females aged 9 - 25 years using an alternative schedule and an alternative dosing as compared to the standard schedule and dosing

• Conditions: For active immunization of females for the prevention of cervical cancer by protecting against persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US), cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions (CIN 2/3) caused by oncogenic human papillomavirus (HPV) types 16 and 18.; MedDRA version: 14.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-002777-32-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-07
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 960

Inclusion Criteria

•Subjects who the investigator believes that they and/or their parents can and will comply with the requirements of the protocol should be enrolled in the study.
•A female subject between, and including, 9 and 25 years of age at the time of the first vaccination.
•Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below the legal age of consent, written informed consent from the subject’s parents/legally acceptable representative, and written informed assent must be obtained from the subject.
•Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
•Subjects 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 continue such precautions for two months after completion of the vaccination series.
Are the trial subjects under 18? yes
Number of subjects for this age range: 480
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
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 vaccines 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,>0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•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 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.
•Pregnant or breastfeeding female.
•A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
•Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (up to Month 24).
•Previous administration of MPL or AS04 adjuvant.
•Cancer or autoimmune disease under treatment.
•Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. MPL, AS04.
•Hypersensitivity to latex (found in syringe-tip cap and plunger).
•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°/Axillary temperature < 37.5°C).
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
•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 (up to Month 24).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified