Know Cancer

forgot password

Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects

Phase 3
26 Years
45 Years
Not Enrolling
Human Papillomavirus (HPV) Type 16/18 Infections, Cervical Neoplasia

Thank you

Trial Information

Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects

This Protocol Posting has been updated following Protocol Amendment 1, December 2010,
leading to:

- The removal of 3 outcome measures

- The update of 1 outcome measure

Inclusion Criteria:

- Written informed consent prior to study enrolment.

- Healthy adult females from Chinese origin and residing in China between and including
26 and 45 years of age at the time of the first vaccination.

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

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

- Subjects must not be pregnant. Absence of pregnancy will be verified with a urine
pregnancy test before each vaccination.

Subjects must be of non-childbearing potential, i.e., have a current tubal ligation,
hysterectomy, ovariectomy, be one year post-menopausal, or if of childbearing potential,
they must be abstinent or have practiced adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test on the day of vaccination and agree to
continue such precautions during the entire treatment period and for 2 months after
completion of the vaccination series.

Exclusion Criteria:

- Use of any investigational or non-registered product other than the study vaccines
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 the first dose of vaccine.

- 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 (pharmaceutical product or device).

- A subject planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the study period and up to two months
after the last vaccine dose.

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

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

- Previous administration of 3-O-desacyl-4'-monophosphoryl lipid A or AS04 adjuvant.

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

- History of hepatitis B infection.

- Known exposure to hepatitis B within the previous 6 weeks.

- History of chronic condition(s) requiring treatment such as cancer or autoimmune

- History of allergic disease, suspected allergy or reactions likely to be exacerbated
by any component of the vaccine (e.g. aluminium).

- Hypersensitivity to latex.

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

- Acute disease at the time of enrolment.

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

Type of Study:


Study Design:

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

Outcome Measure:

Anti-HPV-16 and anti-HPV-18 seroconversion rates assessed by ELISA in women aged 26-45 years and women aged 18-25 years (NCT00779766 study)

Outcome Time Frame:

One month after third vaccination (Month 7)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



China: Jiangsu Center for Disease Control and Prevention

Study ID:




Start Date:

February 2011

Completion Date:

March 2012

Related Keywords:

  • Human Papillomavirus (HPV) Type 16/18 Infections
  • Cervical Neoplasia
  • Safety
  • HPV vaccine
  • Immune response
  • Human papillomavirus
  • China
  • Neoplasms