A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females
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.
|Infections, Papillomavirus||Biological: GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects|
- Number of Subjects Reporting Serious Adverse Events [ Time Frame: Throughout the study period (up to Month 7) ]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.
- Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 7-day (Day 0-6) period following each vaccination ]Solicited local symptoms assessed include pain, redness and swelling.
- Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 7-day (Day 0-6) period following each vaccination ]Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
- Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: Within 30 days (Day 0-29) after any vaccination ]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.
- Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters [ Time Frame: At Month 0 and Month 7 ]
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".
- Number of Subjects Reporting Medically Significant Adverse Events [ Time Frame: Throughout the study period (up to Month7) ]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.
|Study Start Date:||December 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Cervarix Group
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)
Intramuscular injection, 3 doses
Other Name: GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549900
|GSK Investigational Site|
|Jintan City, Jiangsu, China|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|