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

• ClinicalTrials.gov Identifier: NCT01418937
• Recruitment Status: Completed
• First Posted: August 17, 2011
• Results First Posted: August 21, 2015
• Last Update Posted: July 12, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 164 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 26 Years and older (Adult, Older Adult)
• Sexes 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

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

Additional Information:

IPD for this study will be made available via the Clinical Study Data Request site. 

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01418937
• Other Study ID Numbers: 114379
• First Posted: August 17, 2011
• 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.
• URL: https://clinicalstudydatarequest.com

Keywords provided by GlaxoSmithKline:

HPV vaccine; serious adverse events (SAEs); medically significant conditions; cervical neoplasia