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Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: June 28, 2006
Last updated: March 17, 2011
Last verified: March 2011

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
Papillomavirus Vaccines
Biological: Placebo
Biological: HPV-16/18 L1 VLP AS04 (Cervarix TM)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine Administered Intramuscularly ( 0, 1, 6 Month Schedule) in Healthy Women From Malaysia.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Who Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: At Month 7 ] [ Designated as safety issue: No ]
    Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 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:
  • Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: At Month 0 and Month 7 ] [ Designated as safety issue: No ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

  • Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 7 days after each vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.

  • Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: No ]
    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 Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs) [ Time Frame: Throughout the study period (up to Month 7) ] [ Designated as safety issue: No ]

    NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes, allergies,...

    Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or SAEs that are not related to common diseases.

  • Number of Subjects Reporting Serious Adverse Events [ Time Frame: Throughout the study period (up to Month 7) ] [ Designated as safety issue: No ]
    Serious adverse events assessed include medical occurrences that results 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.

Enrollment: 271
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix Group
Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
Biological: HPV-16/18 L1 VLP AS04 (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
Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
Biological: Placebo
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Detailed Description:

The protocol was primarily amended for the following reasons:

  • Merck's tetravalent HPV vaccine, Gardasil®, 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.
  • It was decided to offer GSK Biologicals' HPV vaccine to all subjects in the control group at the end of the study. The HPV vaccine will be offered to these subjects based on its local indication once the vaccine is marketed in Malaysia.

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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 from Malaysia between, and including, 18 and 35 years of age 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 an effective method of birth control 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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • 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. 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 confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Hypersensitivity to latex.
  • Acute disease at the time of enrolment.
  • 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 vaccine(s) or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  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 identifier: NCT00345878

GSK Investigational Site
Kerajaan Persekutuan Putrajaya, Malaysia, 62250
GSK Investigational Site
Kuala Lumpur, Malaysia, 50603
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00345878     History of Changes
Other Study ID Numbers: 105926 
Study First Received: June 28, 2006
Results First Received: November 12, 2009
Last Updated: March 17, 2011
Health Authority: Malaysia: Ministry of Health

Keywords provided by GlaxoSmithKline:
HPV-16/18 L1 VLP AS04
Cervical neoplasia
Cervical cancer
Human Papillomavirus (HPV)

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs processed this record on December 02, 2016