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A Double-Blind, Placebo-Controlled, Randomised Study of the Efficacy of an HPV-16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Healthy Adolescent and Young Adult Women in North America and Brazil.


Phase 2
15 Years
25 Years
Not Enrolling
Female
Papillomavirus Infections

Thank you

Trial Information

A Double-Blind, Placebo-Controlled, Randomised Study of the Efficacy of an HPV-16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Healthy Adolescent and Young Adult Women in North America and Brazil.


Inclusion Criteria:



- Female between and including 15 and 25 years of age at the time of screening (must
not have reached 26th birthday)

- Written informed consent obtained from the subject prior to enrolment (for subjects
below the legal age of consent, written informed consent must also be obtained from a
parent or legal guardian of the subject)

- Free of obvious health problems, as established by medical history and a directed
physical examination

- No more than 6 lifetime sexual partners prior to enrolment

- Intact uterus

- Subject must be of non-childbearing potential, i.e., either surgically sterilised or,
if of childbearing potential, she must be abstinent or must be using an effective
method of birth control for 30 days prior to vaccination, have a negative urine
pregnancy test and must agree to continue such precautions for two months after
completion of the vaccination series

- For subjects not enrolled in the HPV epidemiology study (999910/106) and for subjects
completing the study (999910/106) >90 days prior to enrolment in the present study:
agreement to complete both entrance and exit study questionnaires concerning general
personal information, and sexual, contraceptive, reproductive and other
gynaecological medical history

- For subjects previously enrolled in the HPV epidemiology study (and who completed the
study and an entrance questionnaire) ≤ 90 days prior to enrolment in the present
study: agreement to complete the exit questionnaire only.

- Normal cervical cytology (Pap smear) at screening, using the Cytyc ThinPrep® Pap
Test. A normal Pap smear must also be adequate for interpretation, including the
presence of endocervical cells; a Pap smear that is normal but inadequate for
interpretation must be repeated as part of the protocol

- Seronegative for HPV-16 and HPV-18 antibody by ELISA at screening

- HPV DNA PCR negative for high-risk HPV types by PCR at screening. Genotyping will be
specified using a reverse line probe assay specific for the detection of high-risk
HPV types such as HPV-16, HPV-18 and HPV-16/18-related phylogenetic types

Exclusion Criteria:

- Pregnant or lactating female

- Female planning to become pregnant during the first eight months of the study (months
0-8)

- Abnormal vaginal discharge at the time of entry (once these subjects have received
therapy to eradicate any discharge they will be eligible to participate in study)

- Previous administration of any components of the investigational vaccine

- Chronic administration (defined as more than 14 days) of immuno-suppressants or other
immune-modifying drugs within six months prior to the first vaccine dose.

- Administration of immunoglobulin and/or any blood products within the three months
(90 days) preceding the first dose of study vaccine or planned administration during
the study period

- Planned administration / administration of a vaccine not foreseen by the study
protocol within 30 days of the first dose of study vaccine. Administration of routine
Meningococcal, Hepatitis A, Hepatitis B, Influenza, and Diphtheria/Tetanus vaccine up
to 8 days before the first dose of study vaccine is allowed

- Use of any investigational or non-registered 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

- Receiving or expecting therapy for external or internal condylomata. Subjects with
external condylomata not requiring therapy are eligible to participate in the study

- Genital herpes disease involving the cervix or characterized (on examination or by
history) by extensive external lesions. Subjects with a history of recurrent genital
herpes disease characterized by limited external lesions are eligible to participate
in the study

- History of an abnormal cervical cytology (Pap smear) test (other than a single prior
report of ASCUS with a subsequent normal report)

- Treatment for cervical disease by ablative therapy (cryotherapy or laser ablation) or
excisional therapy (laser cone biopsy, loop excision, cold-knife conization)

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection

- A family history of congenital or hereditary immunodeficiency

- Major congenital defects or serious chronic illness

- History of any neurologic disorders or seizures, with the exception of a single
febrile seizure during childhood

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory screening
tests

- Acute disease at the time of enrolment.

- Oral temperature ≥99.5°F (≥37.5°C) / axillary temperature ≥99.5°F (37.5°C) / rectal
temperature ≥100.4°F (≥38.0°C) / tympanic temperature on oral setting ≥99.5°F
(37.5°C) / tympanic temperature on rectal setting ≥100.4°F (≥38.0°C)

- History of chronic alcohol consumption and/or intravenous drug abuse within the past
2 years

- Known or suspected allergy to any vaccine component

- Hepatomegaly, right upper quadrant abdominal pain or tenderness

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Cervical infection with HPV-16 and/or HPV-18

Outcome Time Frame:

Throughout the study

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

580299/001

NCT ID:

NCT00689741

Start Date:

January 2001

Completion Date:

April 2003

Related Keywords:

  • Papillomavirus Infections
  • HPV
  • vaccine
  • Papillomavirus Infections

Name

Location

GSK Clinical Trials Call CenterChula Vista, California  91911
GSK Clinical Trials Call CenterGainesville, Florida  32610
GSK Clinical Trials Call CenterAtlanta, Georgia  30328
GSK Clinical Trials Call CenterVoorhees, New Jersey  08043
GSK Clinical Trials Call CenterAlbuquerque, New Mexico  87109
GSK Clinical Trials Call CenterPortland, Oregon  97232-2099
GSK Clinical Trials Call CenterLemoyne, Pennsylvania  17043
GSK Clinical Trials Call CenterFort Worth, Texas  76104
GSK Clinical Trials Call CenterOlympia, Washington  98506
GSK Clinical Trials Call CenterMadison, Wisconsin  53792
GSK Clinical Trials Call CenterHooksett, New Hampshire  03106-2505
GSK Clinical Trials Call CenterBardstown, Kentucky  40004
GSK Clinical Trials Call CenterSalt Lake City, Utah  84109