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Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects

Phase 3
18 Years
25 Years
Open (Enrolling)
Prophylaxis for HPV Infections and Associated Cervical Neoplasia.

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Trial Information

Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects

This Protocol Posting has been updated following Protocol Amendment 2 28th March 2011.

Inclusion Criteria:

- Healthy Chinese females between and including 18 and 25 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.

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

- 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.

- Subjects must be of non-childbearing potential, or if of childbearing potential, they
must be abstinent or have practiced adequate contraception for 30 days prior to
vaccination and agree to continue such precautions for 2 months after completion of
the vaccination series.

- Subject must have one single intact cervix.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) 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 (i.e., Days 0-29) the first dose of vaccine.

- Concurrently participating in another clinical study, at any time during the study
period (up to Month 24), 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 (as determined by
the investigator) 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 components of the investigational vaccine.

- 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.

- 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 any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study

- History of having had colposcopy or has planned a colposcopy to evaluate an abnormal
cervical cytology (Pap smear) test.

Type of Study:


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 Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18

Outcome Description:

CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at Months 0 and 6 and seronegative at Month 0 or on subjects DNA- at Months 0 and 6, regardless of initial serostatus.

Outcome Time Frame:

up to Month 24

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



China: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

October 2013

Related Keywords:

  • Prophylaxis for HPV Infections and Associated Cervical Neoplasia.
  • Human papillomavirus
  • vaccine
  • cervical cancer
  • cervical infection
  • Neoplasms