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Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 in Healthy Females 15 - 25 Years of Age

This study is ongoing, but not recruiting participants.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00552279
  Purpose

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
HPV-16/18 Infections and Cervical Neoplasia
Biological: GSK580299
Phase III

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:   Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HPV-16/18 seroconversion rates [ Time Frame: One month after the third vaccine dose ]
  • Anti-HPV-16/18 antibody titres [ Time Frame: One month after the third vaccine dose ]

Secondary Outcome Measures:
  • Anti-HPV-16/18 seroconversion rates and antibody titres [ Time Frame: One month after the second vaccine dose ]
  • The occurrence, intensity and causal relationship to vaccination of solicited local and general symptoms in both groups [ Time Frame: During the 7-day period (day 0 to 6) following each and any vaccination ]
  • The occurrence, intensity and relationship to vaccination of unsolicited symptoms in both groups. [ Time Frame: During the 30-day period (days 0 to 29) following each and any vaccination ]
  • The occurrence, intensity and relationship to vaccination of medically significant conditions, NOCDs, NOADs and SAEs in both groups [ Time Frame: Throughout the study period ]
  • The occurrence of pregnancy and pregnancy outcomes in both HPV vaccine groups [ Time Frame: Throughout the study period ]
  • The percentage of subjects completing the 3-dose vaccination schedule in both groups

Estimated Enrollment:   800
Study Start Date:   November 2007
Estimated Primary Completion Date:   April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Biological: GSK580299
HPV vaccine
2 Biological: GSK580299
HPV vaccine

  Eligibility
Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol
  • A female between and including 15 and 25 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's parents/legally acceptable representative (LAR), and written informed assent must be obtained from the subject.
  • Healthy subjects as established by medical history and/or clinical examination before entering into the study.
  • Subject must be of non-childbearing potential, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative urine pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
  • Subject who had no more than 6 lifetime sexual partners prior to enrolment.

Exclusion Criteria:

  • 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.
  • 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 before and 30 days after the first dose of vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the patient 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 (pharmaceutical product or device).
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
  • previous administration of components of the investigational vaccine
  • Cancer or autoimmune disease under treatment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
  • Pregnant or breastfeeding female.
  • Female planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period starting at visit one and up to two months after the last vaccine dose.
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal function abnormality as determined by physical examination or lab tests.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552279

Locations
Italy
GSK Clinical Trials Call Center    
      Cagliari, Italy, 09127
GSK Clinical Trials Call Center    
      Catania, Italy, 95126
GSK Clinical Trials Call Center    
      Lodi, Italy, 26900
GSK Clinical Trials Call Center    
      Ragusa, Italy, 97100
GSK Clinical Trials Call Center    
      Palermo, Italy, 90127
GSK Clinical Trials Call Center    
      Perugia, Italy, 6122
GSK Clinical Trials Call Center    
      Milano, Italy, 20122
GSK Clinical Trials Call Center    
      Sassari, Italy, 07100
Romania
GSK Clinical Trials Call Center    
      Sibiu, Romania, 550166
GSK Clinical Trials Call Center    
      Bucharest, Romania, 22102
GSK Clinical Trials Call Center    
      Cluj, Romania, 400217
Romania, Ilfov
GSK Clinical Trials Call Center    
      Voluntari, Ilfov, Romania, 77190
Slovakia
GSK Clinical Trials Call Center    
      Trencin, Slovakia, 911 01
GSK Clinical Trials Call Center    
      Nova Dubnica, Slovakia, 018 51
GSK Clinical Trials Call Center    
      Dolny Kubin, Slovakia, 026 01

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     Clinical Trials     GlaxoSmithKline    
  More Information


Responsible Party:   GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:   109179
First Received:   October 30, 2007
Last Updated:   April 24, 2008
ClinicalTrials.gov Identifier:   NCT00552279
Health Authority:   Italy: AIFA - Italian Ministry of Health;   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HPV  
cervical cancer  
papillomavirus  
Human papillomavirus (HPV) vaccine  

Study placed in the following topic categories:
Uterine Cervical Neoplasms
Healthy

ClinicalTrials.gov processed this record on October 07, 2008




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