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A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above


Phase 3
26 Years
N/A
Open (Enrolling)
Female
Prophylaxis for HPV Infections and Associated Cervical Neoplasia

Thank you

Trial Information

A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above


The Protocol Posting has been updated due to protocol amendment 5 and in order to comply
with the FDA Amendment Act, Sep 2007.

Inclusion Criteria


Inclusion criteria:

- A woman who the investigator believes that she can and will comply with the
requirements of the protocol.

- A women of at least 26 years of age at the time of the first vaccination.

- Written informed consent obtained from the subject prior to enrolment.

- Free of obvious health problems as established by medical history and clinical
examination before entering into the study.

- Subject must have intact cervix.

- Subject must have a negative urine pregnancy test. This test is not applicable to
women of non-childbearing potential.

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

Exclusion criteria:

- Pregnant or breastfeeding (women must be at least three months post-pregnancy and not
breastfeeding to enter the study).

- A women planning to become pregnant, likely to become pregnant (as determined by the
investigator) or planning to discontinue contraceptive precautions during the
vaccination phase of the study, i.e. up to two months after the last vaccine dose
(Month 0 - 8).

- 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 (up to Month 84).

- 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) the first dose of study
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 subject is outside of specified window.

- Previous administration of components of the investigational vaccine

- Previous vaccination against HPV or planned administration of any HPV vaccine other
than that foreseen by the study protocol during the study period.

- History of HPV infection/treatment or planned treatment to evaluate an abnormal
cervical cytology (Pap smear) test, e.g. colposcopy.

- 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 vaccine.

- Hypersensitivity to latex.

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

- History of chronic condition(s) requiring treatment.

- Administration of immunoglobulins and/or any blood product within three months
preceding the first dose of study vaccine, or planned administration during the study
period. Enrolment 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 (and no cervical sample can be taken). Enrolment will be
deferred until condition is resolved according to investigators medical judgement.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.

Outcome Description:

CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus

Outcome Time Frame:

Up to Month 48

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Peru: Instituto Nacional de Salud

Study ID:

104820

NCT ID:

NCT00294047

Start Date:

February 2006

Completion Date:

March 2014

Related Keywords:

  • Prophylaxis for HPV Infections and Associated Cervical Neoplasia
  • Vaccine
  • Human papillomavirus
  • Cervical Cancer
  • Cervical Infection
  • Neoplasms

Name

Location

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 SiteGreen Bay, Wisconsin  54301
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteHooksett, New Hampshire  03106
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteOmaha, Nebraska  68131
GSK Investigational SiteOregon City, Oregon  97045
GSK Investigational SiteSalt Lake City, Utah  84107
GSK Investigational SiteSeattle, Washington  98133