Back to resultsA 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.
Primary Purpose
Human Papillomavirus Infection Leading to Cervical Cancer
Status
Terminated
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Cervarix
Sponsored by
About this trial
This is an interventional prevention trial for Human Papillomavirus Infection Leading to Cervical Cancer focused on measuring Cervarix, Filipinos, Safety and reactogenicity, Human papillomavirus
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their LAR's can and will comply with the requirements of the protocol should be enrolled in the study.
- A female 10 years of age and above 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 parent or legal guardian (legally acceptable representative -LAR) of the subject and informed assent must be obtained from the subject.
- Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study.
- Subjects of childbearing potential must not be pregnant.
- Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) 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(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device).
- Pregnant or breastfeeding.
- Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
- Hypersensitivity to latex (found in syringe-tip cap and plunger).
- Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- Cancer or autoimmune disease under treatment.
- Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
- Acute disease at the time of enrolment.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cervarix Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
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
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)
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)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00730847
Brief Title
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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
GSK received exemption from PDFDA on conduct of this post-marketing surveillance (PMS) study.
Study Start Date
September 17, 2008 (Actual)
Primary Completion Date
January 16, 2012 (Actual)
Study Completion Date
January 16, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of Philippines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infection Leading to Cervical Cancer
Keywords
Cervarix, Filipinos, Safety and reactogenicity, Human papillomavirus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
743 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervarix Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Cervarix
Other Intervention Name(s)
HPV-16/18 VLP/AS04 vaccine
Intervention Description
Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Description
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).
Time Frame
During the 7-day follow-up period (Days 0-6) after each dose and across doses
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Description
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.
Time Frame
During the 7-day follow-up period (Days 0-6) after each dose and across doses
Title
Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During the 30-day (Days 0-29) post-vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Description
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.
Time Frame
During the entire study period (from Day 0 up to Month 7)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that they and/or their LAR's can and will comply with the requirements of the protocol should be enrolled in the study.
A female 10 years of age and above 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 parent or legal guardian (legally acceptable representative -LAR) of the subject and informed assent must be obtained from the subject.
Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study.
Subjects of childbearing potential must not be pregnant.
Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) 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(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device).
Pregnant or breastfeeding.
Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
Hypersensitivity to latex (found in syringe-tip cap and plunger).
Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
Cancer or autoimmune disease under treatment.
Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
Acute disease at the time of enrolment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ermita, Manila
Country
Philippines
Facility Name
GSK Investigational Site
City
Makati City
ZIP/Postal Code
1231
Country
Philippines
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/SearchAllPostings.aspx?searchparam=107921
Learn more about this trial
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.
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