Know Cancer

or
forgot password

A Phase III, Double-blind, Randomized, Controlled Study to Evaluate Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly (0, 1, 6 Month Schedule) in Healthy Females Aged 18 - 35 Years


Phase 3
18 Years
35 Years
Not Enrolling
Female
HPV-16 Infection, Associated Cervical Neoplasia, HPV-18 Infection

Thank you

Trial Information

A Phase III, Double-blind, Randomized, Controlled Study to Evaluate Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly (0, 1, 6 Month Schedule) in Healthy Females Aged 18 - 35 Years


The protocol was primarily amended for the following reason:

Merck's tetravalent HPV vaccine, GardasilĀ®, has been licensed and is now becoming
commercially available in an increasing number of countries. Therefore, the study procedures
were revised to include questions at every visit to determine if subjects have received an
HPV vaccine outside of the study.

Inclusion Criteria


Inclusion criteria:

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.

- A female of Chinese origin, residing in Hong Kong aged between, and including, 18 and
35 years at the time of the first vaccination.

- Written informed consent obtained from the subject.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Subjects must have a negative urine pregnancy test.

- Subjects of childbearing potential at the time of study entry must be abstinent or
must be using adequate contraceptive precautions for 30 days prior to vaccination and
must agree to continue such precautions for two months after completion of the
vaccination series.

Exclusion criteria:

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

- Pregnant or breastfeeding.

- Planning to become pregnant or likely to become pregnant.

- 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 the first dose of vaccine. 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.

- 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/ control vaccines.

- Hypersensitivity to latex.

- Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular,
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/ control 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Seroconversion rates to HPV-16 and HPV-18 as assessed by enzyme-linked immunosorbent assay (ELISA)

Outcome Time Frame:

At Month 7

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Hong Kong: Department of Health

Study ID:

106001

NCT ID:

NCT00306241

Start Date:

March 2006

Completion Date:

June 2007

Related Keywords:

  • HPV-16 Infection
  • Associated Cervical Neoplasia
  • HPV-18 Infection
  • Cervical neoplasia
  • Cervical cancer
  • Double-blind
  • HPV-16/18 L1 VLP AS04
  • HPV
  • AS04
  • Neoplasms

Name

Location