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Completed

NCT Number: NCT00359619

Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.

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

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Key information

Conditions

Infections, Papillomavirus Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Papillomavirus Vaccines Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A female who enrolled in the study 102115 and received three doses of vaccine.
  • Written informed consent obtained from the subject prior to enrolment.

Exclusion criteria

  • Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
  • Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
  • Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
  • Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

Treatment and study plan

CervarixTM

Biological

Subjects were administered three doses of HPV vaccine

HPV investigational vaccine GSK568893A, different formulations

Biological

Subjects were administered three doses of HPV investigational vaccine

Primary outcomes

  1. Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.

    Time frame: At Months 18, 24, 36 and 48.

    Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).

  2. Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.

    Time frame: At Months 18, 24, 36 and 48.

    Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.

  3. Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies

    Time frame: At Months 18, 24, 36 and 48.

    Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.

  4. Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.

    Time frame: At Months 18, 24, 36 and 48.

    Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.

  5. Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.

    Time frame: At Months 18, 24, 36 and 48.

    Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.

  6. Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies

    Time frame: At Months 18, 24, 36 and 48.

    Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.

Secondary outcomes

  1. Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.

    Time frame: At Months 18, 24, 36 and 48.

    Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.

  2. Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.

    Time frame: At Months 18, 24, 36 and 48.

    Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.

  3. Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.

    Time frame: At Months 18, 24, 36 and 48.

    Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.

  4. Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.

    Time frame: At Months 18, 24, 36 and 48.

    Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.

  5. Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)

    Time frame: From Month 0 to Months 18, 24, 36 and 48

    NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities [MedDRA] Preferred Term)

  6. Number of Subjects With at Least One Medically Significant Condition (MAEs).

    Time frame: From Month 0 to Months 18, 24, 36 and 48

    MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).

  7. Number of Subjects With Any Serious Adverse Events (SAEs).

    Time frame: From Month 0 to Months 18, 24, 36 and 48

    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. Any = Occurrence of any symptom regardless of intensity grade.

  8. Number of Subjects With Pregnancy Outcomes.

    Time frame: From Month 0 to Month 18

    Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.

  9. Number of Subjects With Pregnancy Outcomes.

    Time frame: From Month 0 to Month 24

    Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.

  10. Number of Subjects With Pregnancy Outcomes.

    Time frame: From Month 0 to Month 36

    Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.

  11. Number of Subjects With Pregnancy Outcomes.

    Time frame: From Month 0 to Month 48

    Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 2, 2006
Registry last updated
Jan 2, 2020

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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