- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01418937
Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study
June 14, 2018 updated by: GlaxoSmithKline
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the GSK HPV-023 Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
164
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Campinas, Brazil, 13083-970
- GSK Investigational Site
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Curitiba, Brazil, 80060-150
- GSK Investigational Site
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Fortaleza, Brazil, 60135-225
- GSK Investigational Site
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São Paulo, Brazil, 03015000
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
26 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HPV Group
|
Three intramuscular injections
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Throughout the study period (from Month 0 up to Month 12)
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Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Time Frame: Throughout the study period (from Month 0 up to Month 12)
|
Throughout the study period (from Month 0 up to Month 12)
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|
Number of Subjects With Medically Significant Conditions (MSCs)
Time Frame: Throughout the study period (from Month 0 up to Month 12)
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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.
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Throughout the study period (from Month 0 up to Month 12)
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Number of Pregnant Subjects Reporting Pregnancy Outcomes
Time Frame: Throughout the study period (from Month 0 up to Month 12)
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The pregnancy outcomes were based on reports from pregnant subjects in the study population.
Pregnancy outcomes are pregnancies resulting in live births.
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Throughout the study period (from Month 0 up to Month 12)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 29, 2012
Primary Completion (ACTUAL)
January 9, 2015
Study Completion (ACTUAL)
January 9, 2015
Study Registration Dates
First Submitted
August 12, 2011
First Submitted That Met QC Criteria
August 16, 2011
First Posted (ESTIMATE)
August 17, 2011
Study Record Updates
Last Update Posted (ACTUAL)
July 12, 2018
Last Update Submitted That Met QC Criteria
June 14, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 114379
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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