Evaluation of immunogenicity and safety of two 2-dose Human Papillomavirusthe (HPV) vaccine schedules in 9-14 years old girls.

• Conditions: Cervarix is indicated in females from 10 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV) types 16 and 18. In addition, Cervarix has shown efficacy against persistent infection caused by oncogenic HPV types other than HPV-16 and HPV-18.; MedDRA version: 14.0Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000757-22-IT
• Lead Sponsor: GLAXO SMITHKLINE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-16
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1428

Inclusion Criteria

1. A female between, and including, 9 and 25 years of age at the time of the first vaccination;2.Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form;3.Healthy subjects as established by medical history and clinical examination before entering into the study; 4.Female subjects of non-childbearing potential may be enrolled in the study;5.Nonchildbearing potential is defined as pre-menarche, current tubal ligation,hysterectomy, ovariectomy or post-menopause; 6.Female subjects of childbearing potential may be enrolled in the study, if the subject:a. has practiced adequate contraception for 30 days prior to vaccination,b. has a negative pregnancy test on the day of vaccination, c.has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1095
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 333
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant or breastfeeding;2.A female planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose;3.Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol;4.Child in care;5.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 36);6.Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine/product dose. For corticosteroids, this will mean prednisone = 20 mg/day (for adult subjects) or = 0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed;7.History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines;8.Cancer or autoimmune disease under treatment;9.Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window;10.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);11.Previous administration of MPL or AS04 adjuvant;12.Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. 13.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required);14.Family history of congenital or hereditary immunodeficiency. 15.Major congenital defects or serious chronic illness;16.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine;17.Acute disease and/or fever at the time of enrolment.Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting, or = 38.0°C (100.4°F) on rectal setting;18. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.Enrolment will be deferred until condition is resolved.

Study & Design

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