Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Papillomavirus

Treatments: Biological: Engerix-BTM; Biological: GSK580299 (CervarixTM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01277042

114590

Details and patient eligibility

About

This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects will receive the HPV vaccine and the other group will receive an active control (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).

Full description

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to:

• The removal of 3 outcome measures
• The update of 1 outcome measure

Enrollment: 1,212 patients

Sex: Female

Ages: 26 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent prior to study enrolment.
• Healthy adult females from Chinese origin and residing in China between and including 26 and 45 years of age at the time of the first vaccination.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• 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 of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy, be one year post-menopausal, 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 on the day of vaccination and agree to continue such precautions during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine.
• 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).
• A subject planning to become pregnant, likely to become pregnant 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 3-O-desacyl-4'-monophosphoryl lipid A or AS04 adjuvant.
• Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.
• History of hepatitis B infection.
• Known exposure to hepatitis B within the previous 6 weeks.
• 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.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,212 participants in 2 patient groups

Cervarix Group

Experimental group

Description:

Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Treatment:

Biological: GSK580299 (CervarixTM)

Engerix Group

Active Comparator group

Description:

Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Treatment:

Biological: Engerix-BTM