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Efficacy of GSK Bio HPV Vaccine (580299) vs Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16/18 Cervical Infection & Cervical Neoplasia, Administered Intramuscularly According to 0,1,6 Month Schedule in Healthy Females (15-25 Years)


Phase 3
15 Years
25 Years
Not Enrolling
Female
Human Papillomavirus (HPV) Infection, Cervical Neoplasia

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Trial Information

Efficacy of GSK Bio HPV Vaccine (580299) vs Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16/18 Cervical Infection & Cervical Neoplasia, Administered Intramuscularly According to 0,1,6 Month Schedule in Healthy Females (15-25 Years)


NOTE: Some 178 centers participate in this study. Given that the recruitment is completed,
the researchers have listed one center per country in this website. If required, further
details of centers available on request.


Inclusion Criteria:



- A woman whom the investigator believes that she and/or her parents/legally acceptable
representative 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, 15 and 25 years of age at the time of the first
vaccination.

- Written informed consent must be obtained from the subject prior to enrollment (for
subjects below the legal age of consent, written informed consent must be obtained
from a parent or legal guardian of the subject and, in addition, the subject should
sign and personally date a written informed assent).

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

- Subject must have a negative urine pregnancy test.

- Subject must be of non-childbearing potential or, if of childbearing potential, she
must be abstinent or must be using adequate contraceptive precautions for 30 days
prior to the first vaccination and must agree to continue such precautions for two
months after completion of the vaccination series.

- Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion
may not be applicable in subjects less than 18 years of age, according to local
regulatory/ethical requirements.

- Subject must have intact cervix.

Exclusion Criteria:

- 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 nine months of the study (Months 0-8).

- Previous administration of components of the investigational vaccine.

- 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.

- 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 (i.e. days 0-29) each dose of vaccine.
Administration of some 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.

- Previous vaccination against human papillomavirus (HPV).

- History of vaccination against Hepatitis A or a known clinical history of Hepatitis A
disease.

- History of having had colposcopy or has planned a colposcopy to evaluate an abnormal
cervical cytology (Pap smear) test.

- 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 chronic condition(s) requiring treatment.

- Received immunoglobulins and/or blood product within 90 days preceding enrollment.
Enrollment will be deferred until the subject is outside of specified window.

- Acute disease at the time of enrolment.

- 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection

Outcome Description:

CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

Outcome Time Frame:

Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

580299/008

NCT ID:

NCT00122681

Start Date:

May 2004

Completion Date:

November 2009

Related Keywords:

  • Human Papillomavirus (HPV) Infection
  • Cervical Neoplasia
  • Neoplasms

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteLexington, Kentucky  40536-0098
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteAlbuquerque, New Mexico  87109
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteHooksett, New Hampshire  03106
GSK Investigational SiteOklahoma City, Oklahoma  73112
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteBirmingham, Alabama  35209
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteOmaha, Nebraska  68131
GSK Investigational SiteEdison, New Jersey  08837
GSK Investigational SiteOregon City, Oregon  97045
GSK Investigational SiteSalt Lake City, Utah  84107
GSK Investigational SiteSeattle, Washington  98133
GSK Investigational SiteHonolulu, Hawaii  96826