Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849381
First received: February 19, 2009
Last updated: September 4, 2014
Last verified: August 2014
  Purpose

This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine).


Condition Intervention Phase
Infections, Papillomavirus
Biological: GSK580299, GSK Biological's HPV vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female Brazilian, Taiwanese and Thai Subjects Who Had Received Control Vaccine in Study 580299/008

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (up to Month 12) ] [ Designated as safety issue: No ]

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Note: Results from one center where compliance issues were discovered are presented also separately.


  • Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs) [ Time Frame: During the entire study period (up to Month 12) ] [ Designated as safety issue: No ]
    MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

  • Number of Subjects With Pregnancies and Pregnancy Outcomes [ Time Frame: During the entire study period (up to Month 12) ] [ Designated as safety issue: No ]
    The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.


Enrollment: 1239
Study Start Date: April 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix Compliance Issue Centre Group
Subjects from one centre where compliance issues were discovered, who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study
Biological: GSK580299, GSK Biological's HPV vaccine
All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
Other Name: CervarixTM
Experimental: Cervarix All Centres Group
Subjects from all study centres who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
Biological: GSK580299, GSK Biological's HPV vaccine
All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.
Other Name: CervarixTM

  Eligibility

Ages Eligible for Study:   26 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study
  • A subject previously enrolled in the primary study (NCT00122681), who received the active control hepatitis A vaccine, and who cannot receive commercially available HPV-16/18 L1 VLP AS04 vaccine because the vaccine has not yet been granted licensure in the subject's country or because the subject is above the age for which the vaccine is licensed.
  • Written informed consent must be obtained from the subject prior to enrolment.
  • A woman aged 26 years or older at the time of the first vaccination in this study.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test.
  • Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Pregnant or lactating female. Enrolment should be deferred until three months after pregnancy has been completed or after lactating has ceased.
  • A woman planning to become pregnant or likely to become pregnant or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the extended safety follow-up 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).
  • Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen by protocol.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days (i.e. Day 0-29) of each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
  • Previous administration of components of the investigational vaccine.
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
  • Hypersensitivity to latex.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests, which in the opinion of the investigator precludes administration of the study vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Cancer or autoimmune disease under treatment.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Acute disease at the time of enrolment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849381

Locations
Brazil
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
GSK Investigational Site
Campinas, Brazil, 13083-970
GSK Investigational Site
Curitiba, Brazil, 80060-150
Taiwan
GSK Investigational Site
Taipei, Taiwan, 112
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 114
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10700
GSK Investigational Site
Bangkok, Thailand, 10330
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849381     History of Changes
Other Study ID Numbers: 111758
Study First Received: February 19, 2009
Results First Received: November 27, 2013
Last Updated: September 4, 2014
Health Authority: Taiwan: Department of Health
Brazil: ANVISA
Thailand: Royal Thai Army Medical Department

Keywords provided by GlaxoSmithKline:
HPV
HPV vaccine
papillomavirus
cervical cancer
human papillomavirus

ClinicalTrials.gov processed this record on October 22, 2014