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Completed

NCT Number: NCT00578227

Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.

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Key information

Conditions

Infections, Papillomavirus Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

9 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Surrey, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who the investigator believes that they and/or their legally acceptable representatives (LARs) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination.
  • Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's LAR, and written informed assent must be obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects must not be pregnant.
  • Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or use adequate contraception 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 vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
  • Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • 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(s). Administration of routine vaccines may be allowed up to 8 days before the first dose
  • A subject planning to become pregnant, likely to become pregnant 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 A or B planned administration of any hepatitis A or B vaccine other than that foreseen by the study protocol during the study period.
  • History of hepatitis A or B infection.
  • Known exposure to hepatitis A or 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.

Treatment and study plan

Cervarix™

Biological

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Other names: HPV vaccine, GSK Biologicals' HPV-16/18 L1 AS04

Twinrix ™ Paediatric

Biological

Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

Primary outcomes

  1. Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies

    Time frame: At Month 7

    Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.

  2. Anti-Heptatis A (HAV) Antibody Titers.

    Time frame: At Month 7

    Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.

  3. Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies

    Time frame: At Month 7

    A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.

  4. 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: At Month 7

    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 = 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.

  5. Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers

    Time frame: At Month 7

    Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

Secondary outcomes

  1. Anti-HBs Antibody Titers

    Time frame: At Month 7

    Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.

  2. Number of Subjects Seroconverted for Anti-HBs Antibodies

    Time frame: At month 7

    Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.

  3. Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years

    Time frame: At Month 7

    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 = 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.

  4. Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years

    Time frame: At Month 7

    Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

  5. Number of Subjects Seroconverted for Anti-HAV Antibodies

    Time frame: One month after the second dose of vaccine

    Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.

  6. Anti-HAV Antibody Titers

    Time frame: One month after the second dose of vaccine

    Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.

  7. Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies

    Time frame: One month after the second dose of vaccine

    Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.

    A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.

  8. Anti-HBs Antibody Titers

    Time frame: One month after the second dose of vaccine

    Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.

  9. 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 after the second dose of vaccine

    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.

  10. Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers

    Time frame: One month after the second dose of vaccine

    Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.

  11. Number of Subjects Reporting Solicited Local Symptoms

    Time frame: During the 7-day period (Day 0-6) following vaccination

    Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.

  12. Number of Subjects Reporting Solicited General Symptoms

    Time frame: During the 7-day period following vaccination

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

  13. Number of Subjects Reporting Medically Significant Conditions

    Time frame: Throughout the active phase of the study (up to Month 7)

    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.

  14. Number of Subjects Reporting Medically Significant Conditions

    Time frame: Throughout the safety follow-up (from Month 7 up to Month 12)

    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.

  15. Number of Subjects Reporting Unsolicited Adverse Events

    Time frame: During the 30-day period following any vaccination

    Unsolicited adverse events include 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.

  16. Number of Subjects Reporting Serious Adverse Events (SAE)

    Time frame: Throughout the study (up to Month 12)

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Dec 21, 2007
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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