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Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study

Phase 3
26 Years
Open (Enrolling)
Human Papillomavirus (HPV) Type 16/18 Infections, Cervical Neoplasia

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Trial Information

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study

This Protocol Posting has been updated following Protocol Amendment 1, December 2010,
leading to the update of 1 of the primary outcome measures and following Protocol Amendment
2, January 2011, leading to the removal of one of the exclusion criteria.

Inclusion Criteria:

- Subjects who the investigator believes can and will comply with the requirements of
the protocol

- A subject previously enrolled in study NCT00294047, who received the control vaccine,
and who cannot receive the GSK580299 vaccine because the subject is above the age for
which the vaccine is licensed.

- Written informed consent obtained from the subject

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

- Female subjects of non-childbearing potential may be enrolled in the study.

- Female subjects of childbearing potential may be enrolled in the study, if the

- has practiced adequate contraception for 30 days prior to vaccination, and

- has a negative pregnancy test on the day of vaccination, and

- has agreed to continue adequate contraception during the entire treatment period
and for 2 months after completion of the vaccination series.

Exclusion Criteria:

- Pregnant or breastfeeding.

- A women planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the vaccination phase of the study, i.e.
up to two months after the last vaccine dose.

- Use of any investigational or non-registered product other than the study vaccine
within 30 days preceding the first dose of study vaccine, or planned use during the
study period.

- Previous vaccination against HPV or planned administration of another HPV vaccine
during the study other than that foreseen in the protocol.

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose. For corticosteroids, this will mean
prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical
steroids are allowed

- Planned administration/administration of a vaccine not foreseen by the study protocol
within 30 days (i.e., Day 0-29) of each dose of vaccine, with the exception of
administration of routine meningococcal, hepatitis B, hepatitis A, inactivated
influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8
days before each dose of study vaccine. Enrolment will be deferred until the subject
is outside of specified window.

- 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.

NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological
follow-up of the HPV-015 study, in which no investigational product will be administered.
Subjects will be invited to the gynaecological follow-up study if either of the following

- if they test positive for oncogenic HPV infection, but display normal cervical
cytology at their concluding HPV-015 study end visit;

- if they are pregnant so that no cervical sample can be taken at their concluding
HPV-015 study end visit;

- Previous administration of any components of the vaccine.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based
on medical history and physical examination.

- Cancer or autoimmune disease under treatment.

- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the
study period.

- History of any reaction or hypersensitivity likely to be exacerbated by any
component of the vaccine

- History of any neurological disorders or seizures.

- Acute disease and/or fever at the time of enrolment.

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Occurrence, intensity and causal relationship to vaccination of serious adverse events

Outcome Time Frame:

Throughout the study (from Month 0 to 12)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Canada: Health Products and Food Branch

Study ID:




Start Date:

April 2011

Completion Date:

July 2015

Related Keywords:

  • Human Papillomavirus (HPV) Type 16/18 Infections
  • Cervical Neoplasia
  • Serious adverse events (SAEs)
  • HPV vaccine
  • Medically significant conditions
  • Cervical neoplasia
  • Neoplasms



GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Lexington, Kentucky  40536-0098
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Aurora, Colorado  80012
GSK Investigational Site Kansas City, Kansas  66160
GSK Investigational Site Salt Lake City, Utah  84107