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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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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 : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Biological: Cervarix
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



Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
Philippines
GSK Investigational Site
Ermita, Manila, Philippines
GSK Investigational Site
Makati City, Philippines, 1231
GSK Investigational Site
Manila, Philippines, 1004
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00730847     History of Changes
Other Study ID Numbers: 108160
First Posted: August 8, 2008    Key Record Dates
Results First Posted: December 21, 2012
Last Update Posted: March 15, 2018
Last Verified: February 2018

Keywords provided by GlaxoSmithKline:
Cervarix
Filipinos
Safety and reactogenicity
Human papillomavirus

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Papillomavirus Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs