A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00730847|
Recruitment Status : Terminated (GSK received exemption from PDFDA on conduct of this post-marketing surveillance (PMS) study.)
First Posted : August 8, 2008
Results First Posted : December 21, 2012
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus Infection Leading to Cervical Cancer||Biological: Cervarix||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||743 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Post-marketing Surveillance (PMS) Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in 3,000 Healthy Female Filipino Subjects When Administered According to the Prescribing Information From the Age of 10 Years Onwards.|
|Actual Study Start Date :||September 17, 2008|
|Actual Primary Completion Date :||January 16, 2012|
|Actual Study Completion Date :||January 16, 2012|
Experimental: Cervarix Group
Healthy female subjects who received three doses of the Cervarix vaccine, administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.
Other Name: HPV-16/18 VLP/AS04 vaccine
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses ]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 the 7-day follow-up period (Days 0-6) after each dose and across doses ]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 study vaccination. Related = symptoms considered by the investigator as causally related to study 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 the 30-day (Days 0-29) post-vaccination period ]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 study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.
- Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 up to Month 7) ]SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
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): NCT00730847
|GSK Investigational Site|
|Ermita, Manila, Philippines|
|GSK Investigational Site|
|Makati City, Philippines, 1231|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|