Evaluate Safety of a Vaccine Against Cervical Cancer (HPV-16/18 L1/AS04) in Healthy Filipino Females Aged 10 Yrs & Above
This study will collect clinical data (safety and reactogenicity) of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in the local target population as per the Bureau of Food and Drugs Directive of Philippines.
HPV-16/18 Infections and Associated Cervical Neoplasia
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Post-marketing Surveillance Study to Monitor Safety of Vaccination (Accor to Prescribing Information) With GlaxoSmithKline Biologicals' Human Papillomavirus Vaccine (HPV-16/18 L1/AS04) in Healthy Filipino Females (3,000; Aged >/= 10 Yrs)|
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [ Time Frame: During a 7-day follow-up period (Days 0-6) after any vaccination ] [ Designated as safety issue: No ]Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During a 7-day follow-up period (Days 0-6) after any vaccination ] [ Designated as safety issue: No ]Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator as causally related to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature >39.0°C.
- Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During a 30-day (Days 0-29) post-vaccination period ] [ Designated as safety issue: No ]An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigators as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigators as causally related to the study vaccination.
- Number of Subjects With Grade 3, Any and Related Serious Adverse Events (SAEs) [ Time Frame: Throughout the study period (up to Month 7). ] [ Designated as safety issue: No ]SAEs assessed include 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. Grade 3 SAE = SAE which prevented normal, everyday activities. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
|Study Start Date:||September 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Cervarix Group
Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Subjects received three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
|GSK Investigational Site|
|Ermita, Manila, Philippines|
|GSK Investigational Site|
|Makati City, Philippines, 1231|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|