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A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00485732
First received: June 12, 2007
Last updated: November 3, 2016
Last verified: November 2016
  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 GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.

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


Condition Intervention Phase
Infections, Papillomavirus Biological: HPV-16/18 VLP/AS04 vaccine (Cervarix TM) Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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:
  • Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: One month post Dose 3 (Month 7) ]

    Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.

    Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.



Secondary Outcome Measures:
  • Anti-HPV-16 and Anti-HPV-18 Antibody Titres [ Time Frame: Before vaccination (PRE) and one month post Dose 3 (Month 7) ]
    Titres are given as geometric mean titres (GMTs) calculated on all subjects.

  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) period following each vaccination ]
    Solicited local symptoms assessed include pain, redness and swelling at the injection site.

  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) period following each vaccination ]
    Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.

  • Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 30-day (Days 0-29) period following each vaccination ]
    Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

  • Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions [ Time Frame: From Day 0 up to Month 7 ]
    NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses.

  • Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: From Day 0 up to Month 7 ]
    Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

  • Number of Subjects With Pregnancies and Their Outcome [ Time Frame: from Day 0 up to Month 7 ]
    Total: the total number of pregnancies in a group. The specific outcomes are also listed.


Enrollment: 225
Study Start Date: June 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix Group Biological: HPV-16/18 VLP/AS04 vaccine (Cervarix TM)
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Other Name: GSK Biologicals' HPV-16/18 VLP/AS04 vaccine
Placebo Comparator: Placebo Group Biological: Placebo
Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485732

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

Additional Information:
Publications:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107291
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 107291
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107291
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107291
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107291
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 107291
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107291
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00485732     History of Changes
Other Study ID Numbers: 107291
Study First Received: June 12, 2007
Results First Received: November 12, 2009
Last Updated: November 3, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017