Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Females Aged 15-25 Years.
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00485732
  Purpose

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the HPV-16/18 L1 VLP AS04 vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Human Papillomavirus (HPV) Infection
Associated Cervical Neoplasia
Biological: HPV-16/18 L1 VLP AS04
Phase III

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase IIIb, Double-Blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly in Healthy Female Subjects Aged 15 - 25 Years.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Seroconversion rates to HPV-16 and HPV-18 [ Time Frame: At Month 7 ]

Secondary Outcome Measures:
  • Occurrence of SAEs [ Time Frame: Throughout the study period (up to Month 7) ]
  • Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity of solicited local symptoms [ Time Frame: During the 7 days after each and any vaccination ]
  • Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms [ Time Frame: Within 30 days after any vaccination ]
  • Anti-HPV-16/18 antibody titres [ Time Frame: At Month 0 and Month 7 ]
  • The occurrence of new onset chronic diseases and other medically significant conditions in all groups regardless of causal relationship to vaccination and intensity. [ Time Frame: Throughout the study period (up to Month 7) ]

Estimated Enrollment: 225
Study Start Date: June 2007
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female between, and including, 15 and 25 years of age at the time of the first vaccination.
  • Written informed assent obtained from the subject and informed consent obtained from the parent or guardian of 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 (defined as more than 14 days) 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. However, the 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 such as HIV infection based on medical history and physical examination.
  • History of thrombocytopenia or hemostatic disorder in which case the study vaccine should under no circumstances be administered intramuscularly.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485732

Locations
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 150-879
GSK Investigational Site
Seoul, Korea, Republic of, 137-040
GSK Investigational Site
Seoul, Korea, Republic of, 158-710
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 107291
Study First Received: June 12, 2007
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00485732  
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:
Phase IIIb
Double-blind
Randomized
Controlled
HPV
HPV-16/18 L1 VLP AS04
AS04
Cervical cancer
Cervical neoplasia
Korea

Study placed in the following topic categories:
Healthy

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on January 16, 2009