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Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00637195
First received: February 28, 2008
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals' HPV vaccine GSK580299 in healthy female subjects.


Condition Intervention Phase
Hepatitis B
Cervical Intraepithelial Neoplasia
Human Papillomavirus Infection
Biological: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™)
Biological: Engerix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Immunogenicity and Safety of a Commercially Available Vaccine When Co-administered With GlaxoSmithKline Biologicals' HPV Vaccine (580299) in Healthy Female Subjects.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).

  • Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).


Secondary Outcome Measures:
  • Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies [ Time Frame: Months 2 and 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 subject 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.


  • Anti-HPV-16/18 Antibody Titers [ Time Frame: Months 2 and 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 Seroconverted for Anti-hepatitis B (HBs) Antibodies [ Time Frame: Months 2, 3 and 13 ] [ Designated as safety issue: No ]
    Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.

  • Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course [ Time Frame: Months 2 and 13 ] [ Designated as safety issue: No ]
    A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.

  • Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course [ Time Frame: At Months 2 and 13 ] [ Designated as safety issue: No ]
    Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.

  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 7-day period following any vaccination ] [ Designated as safety issue: No ]

    Solicited local symptoms assessed include injection site pain, redness and swelling.

    Data are presented across doses.


  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 7-day period following the 4th dose of HBV vaccine ] [ Designated as safety issue: No ]

    Solicited local symptoms assessed include injection site pain, redness and swelling.

    Data are presented across doses.


  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 7-day period following any vaccination ] [ Designated as safety issue: No ]

    Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.

    Data are presented across doses.


  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 7-day period following the 4th dose of HBV vaccine ] [ Designated as safety issue: No ]

    Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.

    Data are presented across doses.


  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: During the 30-day period following any vaccination ] [ Designated as safety issue: No ]
    Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: During the 30-day period following the 4th dose of HBV vaccine ] [ Designated as safety issue: No ]
    Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  • Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: Up to study end (Month 13) ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are 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 Reporting Medically Significant Conditions [ Time Frame: Up to study end (Month 13) ] [ Designated as safety issue: No ]
    Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.


Enrollment: 152
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix™ & Engerix™ Group
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Biological: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™)
Intramuscular administration, 3 doses.
Other Name: GSK Biologicals' HPV vaccine 580299
Biological: Engerix™
Intramuscular administration, 4 doses.
Other Name: GSK Biologicals' vaccine 103860
Active Comparator: Engerix™ Group
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Biological: Engerix™
Intramuscular administration, 4 doses.
Other Name: GSK Biologicals' vaccine 103860

  Eligibility

Ages Eligible for Study:   20 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 between, and including, 20 and 25 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 history directed clinical examination before entering into the study.
  • Subjects must not be pregnant.
  • Subjects must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 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 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 each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine is allowed.
  • Concurrently participating in another clinical study, at any time during the study period (up to Month 13), 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 women.
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period
  • Previous administration of components of the investigational vaccine.
  • 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.
  • Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
  • Cancer or autoimmune disease under treatment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • 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 period.
  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: NCT00637195

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
La Louvière, Belgium, 7100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00637195     History of Changes
Other Study ID Numbers: 111567
Study First Received: February 28, 2008
Results First Received: November 12, 2009
Last Updated: June 14, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:
Human papillomavirus (HPV) vaccine
Hepatitis B
Cervical cancer
HPV
Papillomavirus

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Hepatitis
Hepatitis B
Papillomavirus Infections
Carcinoma
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014