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Trial record 68 of 91 for:    cervarix

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01418937
Recruitment Status : Completed
First Posted : August 17, 2011
Results First Posted : August 21, 2015
Last Update Posted : July 12, 2018
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Infections, Papillomavirus Biological: CervarixTM (GSK580299) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 29, 2012
Actual Primary Completion Date : January 9, 2015
Actual Study Completion Date : January 9, 2015

Arm Intervention/treatment
Experimental: HPV Group Biological: CervarixTM (GSK580299)
Three intramuscular injections

Primary Outcome Measures :
  1. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: Throughout the study period (from Month 0 up to Month 12) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  2. Number of Subjects With Potential Immune-mediated Disease (pIMDs) [ Time Frame: Throughout the study period (from Month 0 up to Month 12) ]
  3. Number of Subjects With Medically Significant Conditions (MSCs) [ Time Frame: Throughout the study period (from Month 0 up to Month 12) ]
    MSCs include AEs 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.

  4. Number of Pregnant Subjects Reporting Pregnancy Outcomes [ Time Frame: Throughout the study period (from Month 0 up to Month 12) ]
    The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.

Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT01418937

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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
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
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Responsible Party: GlaxoSmithKline Identifier: NCT01418937     History of Changes
Other Study ID Numbers: 114379
First Posted: August 17, 2011    Key Record Dates
Results First Posted: August 21, 2015
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
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.

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

Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs