Immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Human Papillomavirus (HPV) 580299 vaccine in healthy Chinese female subjects.

• Conditions: Healthy volunteers; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003025-25-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-11
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

•Subjects who the investigator believes that they 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).
•Healthy Chinese females between and including 9 and 17 years of age at the time of the first vaccination.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
•Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
•Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test before each vaccination.
•Subjects must be either of non-childbearing potential (e.g. pre-menarcheal or surgically sterilised), or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and agree to continue such precautions for 2 months after completion of the vaccination series.

Are the trial subjects under 18? yes
Number of subjects for this age range: 750
F.1.2 Adults (18-64 years) no
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 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 > 0.5 mg/kg/day or equivalent. 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.
•Concurrently participating in another clinical study, at any time during the study period (i.e. from Day 0 up to the telephone contact at Month 12), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•A subject 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. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
•Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.
•Previous administration of components of the study vaccine (MPL or AS04 adjuvant).
•History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
•History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine (e.g. aluminium).
•Hypersensitivity to latex (found in syringe-tip cap and plunger).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•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/axillary temperature >37.0°C).
•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.

Study & Design

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