Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01418937
First received: August 12, 2011
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741) study.


Condition Intervention Phase
Infections, Papillomavirus
Biological: CervarixTM (GSK580299)
Phase 3

Study Type: Interventional
Study Design: 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 (GSK-580299) in Healthy Female Control Subjects From the GSK HPV-023 Study

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of medically significant conditions and potential immune-mediated diseases (pIMDs). [ Time Frame: Throughout the study period (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs). [ Time Frame: Throughout the study period (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
  • Occurrence of pregnancies [ Time Frame: Throughout the study period (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
  • Pregnancy outcomes [ Time Frame: Throughout the study period (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: May 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPV Group
Not Applicable
Biological: CervarixTM (GSK580299)
Three intramuscular injections

  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 can and will comply with the requirements of the protocol.
  • A subject previously enrolled in Study HPV-023 (NCT00518336), who received placebo in Study HPV-001 (NCT00689741), and who is 26 years of age or older.
  • Written informed consent must be obtained from the subject prior to enrollment.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Pregnant or breastfeeding: enrollment should be deferred to at least three months after delivery and after breastfeeding is ceased.
  • A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, and up to two months after the last vaccine dose.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of the vaccine, with the exception of 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. Enrollment will be deferred until the subject is outside of specified window.
  • 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 a non-investigational product.
  • Previous administration of vaccine components.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Cancer or autoimmune disease under treatment.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • History of any neurological disorders or seizures.
  • Acute disease and/or fever at the time of enrollment. Enrollment will be deferred until condition is resolved.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.
  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: NCT01418937

Locations
Brazil
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
GSK Investigational Site
Campinas, Brazil, 13083-970
GSK Investigational Site
Curitiba, Brazil, 80060-150
GSK Investigational Site
Fortaleza, Brazil, 60135-225
GSK Investigational Site
São Paulo, Brazil, 03015000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01418937     History of Changes
Other Study ID Numbers: 114379
Study First Received: August 12, 2011
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration
Brazil: ANVISA - Agência Nacional de Vigilância Sanitaria

Keywords provided by GlaxoSmithKline:
HPV vaccine
serious adverse events (SAEs)
medically significant conditions
cervical neoplasia

ClinicalTrials.gov processed this record on July 31, 2014