Clinical trial NCT01277042: Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)
Official title: Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Keywords: Safety
HPV vaccine
Immune response
Human papillomavirus
China
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-01-14
Enrollment: 1212
Sex: FEMALE
Minimum age (years): 26
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18
timeFrame: One month after third vaccination (Month 7)
Secondary outcomes:
measure: Number of Subjects Seropositive Against HPV-16 and HPV-18
timeFrame: Before vaccination (Month 0) and one month after third vaccination (Month 7)
measure: Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies
timeFrame: Before vaccination (Month 0) and one month after third vaccination (Month 7)
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7 days (Days 0 - 6) after any vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7 days (Days 0 - 6) after any vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
timeFrame: Throughout the study (from Month 0 up to Month 12)
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: Within 30 days (Days 0 - 29) after any vaccination
measure: Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)
timeFrame: Throughout the study (from Month 0 up to Month 12)
measure: Number of Subjects With Outcome of Pregnancies
timeFrame: Throughout the study (from Month 0 up to Month 12)
Other outcomes:
Locations:
city: Jintan
country: China
facility: GSK Investigational Site
state: Jiangsu
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Zhu F, Li J, Hu Y, Zhang X, Yang X, Zhao H, Wang J, Yang J, Xia G, Dai Q, Tang H, Suryakiran P, Datta SK, Descamps D, Bi D, Struyf F. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years. Hum Vaccin Immunother. 2014;10(7):1795-806. doi: 10.4161/hv.28702.