A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females

Study Overview
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Brief Summary
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A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM), administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female subjects aged 15 - 45 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description
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The rationale for the protocol posting amendment was to change the study population from 18-35 to 15-45 years and to allow subjects who were administered routine vaccines e.g. Hepatitis A&B vaccines, meningococcal vaccines, Tetanus vaccine, Diphteria Tetanus Pertussis etc. up to 8 days before each HPV dose.

Official Title
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Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects

Conditions
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Infections, Papillomavirus

Intervention / Treatment
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* Biological: GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. A female of Chinese origin, residing in China, aged between 15 - 45 years (inclusive) at the time of the first vaccination. Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the subject's parent or Legally Acceptable Representative (LAR), and written informed assent must be obtained from the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Subjects must have a negative urine pregnancy test. Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or must be using adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series. Exclusion Criteria: 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. Pregnant or breastfeeding. Planning to become pregnant or likely to become pregnant Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. 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. Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days preceding and 30 days after the first dose of vaccine. Administration of some routine vaccines up to 8 days before the first dose of study vaccine is allowed. Previous administration of components of the investigational vaccine. Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine. Hypersensitivity to latex. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Known acute or chronic, clinically significant system conditions. Cancer or autoimmune disease under treatment. Acute disease at the time of enrolment. History of chronic alcohol consumption and/or drug abuse.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervarix Group<br>Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule. | Biological: GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)<br>* Intramuscular injection, 3 doses<br>* Other names: GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Serious Adverse Events | Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | Throughout the study period (up to Month 7) | 
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | During the 7-day (Day 0-6) period following each vaccination | 
| Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria. | During the 7-day (Day 0-6) period following each vaccination | 
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | Within 30 days (Day 0-29) after any vaccination | 
| Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters | Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below. | At Month 0 and Month 7 | 
| Number of Subjects Reporting Medically Significant Adverse Events | Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. | Throughout the study period (up to Month7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV vaccine,, Cervical cancer, Human papillomavirus infection,