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Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 in Healthy Females 10 - 25 Years of Age.
This study is currently recruiting participants.
Verified by GlaxoSmithKline, September 2008
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00481767
  Purpose

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine 580299 in female subjects aged 10-25 years enrolled in Africa.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
HPV-16/18 Infections
Cervical Neoplasia
Biological: HPV-16/18 L1 VLP AS04 (580299)
Phase III

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase IIIb Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 When Administered in Healthy Adolescent and Adult Female Subjects.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HPV-16 and HPV-18 seroconversion rates and GMTs in subjects 15 - 25 years of age. [ Time Frame: At Month 7 ]
  • HPV-16 and HPV-18 seroconversion rates and GMTs in subjects 10 - 14 years of age. [ Time Frame: At Month 7 ]

Secondary Outcome Measures:
  • HPV-16 and HPV-18 seroconversion rates and GMTs in all subjects. [ Time Frame: At Month 2 and Month 12 ]
  • Occurrence and intensity of solicited local symptoms [ Time Frame: Within 7 days after each and any vaccination ]
  • Occurrence, intensity and causal relationship to vaccination of solicited general symptoms. [ Time Frame: Within 7 days after each and any vaccination ]
  • Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms [ Time Frame: Within 30 days after any vaccination ]
  • Occurrence of NOCDs and other medically significant conditions regardless of causal relationship to vaccination and intensity. [ Time Frame: Up to Month 7 ]
  • Occurrence of SAEs [ Time Frame: Up to Month 7 ]
  • Occurrence of pregnancies (and their outcome) [ Time Frame: Up to Month 7 ]
  • Occurrence of SAEs, NOCDs, other medically significant conditions and pregnancies (and their outcome) [ Time Frame: From Month 7 through the Month 12 follow-up visit ]
  • Occurrence of clinically relevant abnormalities in biochemical and haematological parameters assessed [ Time Frame: At screen visit, Visits 6 and 8 (Day 0, Months 7 and 12) ]

Estimated Enrollment: 666
Study Start Date: October 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   10 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 parents/legally acceptable representative can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female between, and including, 10 and 25 years of age at the time of the first vaccination.
  • Written or oral, signed or thumb printed or witnessed informed consent obtained from the subject prior to enrolment. For subjects below legal age of consent, written or oral, signed or thumb printed or witnessed informed consent obtained from the subject's parent or legally acceptable representative. In addition, a written or oral, signed or thumb printed and witnessed informed assent must be obtained from the subject.
  • Free of obvious health problems as established by medical history, clinical examination and laboratory testing before entering into the study.
  • Subjects must have a negative urine pregnancy test at the screening visit and at Visit 1 (Day 0).
  • Subjects must be seronegative for human immunodeficiency virus (HIV) at the screening visit.
  • Subjects must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
  • Subjects must have had no more than 6 sexual partners prior to enrolment.
  • Subjects must be willing to undergo HIV voluntary counselling and testing and must be willing to be informed of their HIV status. Subjects below legal age of consent must also be willing to have their parent or legally acceptable representative informed of their HIV status.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. Enrolment will be deferred until the subject is outside of specified window.
  • Planned administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after any dose of study vaccine.
  • 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, including HIV infection based on laboratory testing performed during the screening visit.
  • Hypersensitivity to latex
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control.
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.
  • History of any neurologic disorders or seizures.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or breastfeeding female.
  • A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481767

Locations
Senegal
GSK Clinical Trial Call Center Recruiting
Dakar, Senegal
Contact: GSK Clinical Trial Call Center     1-877-379-3718        
Tanzania
GSK Clinical Trial Call Center Not yet recruiting
Mwanza, Tanzania
Contact: GSK Clinical Trial Call Center     1-877-379-3718        
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trial GlaxoSmithKline
  More Information

Responsible Party: GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers: 106069
Study First Received: May 31, 2007
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00481767  
Health Authority: Senegal: Ministere de la sante

Keywords provided by GlaxoSmithKline:
HPV;
Cervical cancer;
Papillomavirus;
Human papillomavirus (HPV) vaccine

Study placed in the following topic categories:
Healthy

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on January 13, 2009