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Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]


Phase 3
18 Years
45 Years
Not Enrolling
Female
Cervical Cancer, Papillomavirus Infection

Thank you

Trial Information

Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]


This Protocol Posting has been updated following Protocol Amendment 25, November 2010


Inclusion Criteria:



- A woman whom the investigator believes that she or her legally acceptable
representative (in the event that the subject is illiterate) can and will comply with
the requirements of the protocol (e.g., completion of the diary cards, return for
follow-up visits).

- A woman between and including 18 and 45 years of age at the time of the first
vaccination.

- Written informed consent must be obtained from the subject prior to enrollment.

- Subject must be free of obvious health problems as established by medical history and
history-directed clinical examination before entering into the study.

- Subject must have a negative urine pregnancy test.

- 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 pregnancy test and continue such precautions for 2 months after
completion of the vaccination series.

- Subject must have an intact cervix.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period up to Month 60.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose or planned
administration during the study period up to Month 60.

- Planned administration/administration of a vaccine not foreseen by the study protocol
within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine.
Administration of routine vaccines up to 8 days before each dose of study vaccine is
allowed. Enrolment will be deferred until the subject is outside of specified window.

- Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not
breastfeeding to enter the study.

- A woman planning to become pregnant or planning to discontinue contraceptive
precautions during approximately the first eight months of the study (Months 0-8).

- Previous administration of components of the investigational vaccine

- Previous or planned vaccination against HPV outside of this protocol.

- Any medically diagnosed or suspected immunodeficient condition based on medical
history and physical examination.

- History of allergic disease, suspected allergy or reactions likely to be exacerbated
by any component of the study vaccines.

- Hypersensitivity to latex.

- Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic,
hepatic or renal functional abnormality, as determined by previous physical
examination or laboratory tests.

- History of significant medical conditions and currently under treatment.

- Received immunoglobulins and/or blood product within 90 days preceding enrolment or
planned administration during the study period up to Month 60. Enrollment will be
deferred until the subject is outside of specified window.

- Acute disease at the time of enrolment. Enrollment will be deferred until condition
is resolved. All vaccines can be administered to persons with a minor illness

- Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic
exam cannot be performed. Enrollment will be deferred until condition is resolved
according to investigator's medical judgement.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Neutralizing Antibody Titers in Females 18-26 Years of Age

Outcome Description:

The data are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.

Outcome Time Frame:

At Month 7

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

108933

NCT ID:

NCT00423046

Start Date:

January 2007

Completion Date:

May 2012

Related Keywords:

  • Cervical Cancer
  • Papillomavirus Infection
  • Vaccines
  • Cervical cancer
  • Immunogenicity
  • Humans
  • Safety
  • Viral infections
  • Human papillomavirus (HPV)
  • Comparative study
  • Human papillomavirus vaccine
  • Adults
  • Uterine Cervical Neoplasms
  • Papillomavirus Infections

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteLexington, Kentucky  40536-0098
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteCoeur d'Alene, Idaho  83814
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteOmaha, Nebraska  68131
GSK Investigational SiteCranston, Rhode Island  02920
GSK Investigational SiteSalt Lake City, Utah  84107
GSK Investigational SiteSeattle, Washington  98133