A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females
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|ClinicalTrials.gov Identifier: NCT00549900|
Recruitment Status : Completed
First Posted : October 26, 2007
Results First Posted : December 17, 2009
Last Update Posted : July 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Infections, Papillomavirus||Biological: GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Immunogenicity Study of the HPV Vaccine (GSK-580299) in Healthy, Chinese, Female Subjects|
|Study Start Date :||December 2, 2007|
|Actual Primary Completion Date :||July 12, 2008|
|Actual Study Completion Date :||July 12, 2008|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549900
|GSK Investigational Site|
|Jintan City, Jiangsu, China|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|