Evaluate Safety of a Vaccine Against Cervical Cancer (HPV-16/18 L1/AS04) in Healthy Filipino Females Aged 10 Yrs & Above

This study has been terminated.
(GSK received exemption from PDFDA on conduct of this post-marketing surveillance (PMS) study)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00730847
First received: August 6, 2008
Last updated: November 21, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
HPV-16/18 Infections and Associated Cervical Neoplasia
Biological: Cervarix
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Enrollment: 596
Study Start Date: September 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Cervarix
Subjects received three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730847

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00730847     History of Changes
Other Study ID Numbers: 108160
Study First Received: August 6, 2008
Results First Received: November 21, 2012
Last Updated: November 21, 2012
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by GlaxoSmithKline:
PMS
Post-marketing surveillance
Safety
Prescribing Information
Philippines
HPV
Human papillomavirus

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014