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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00359619
First received: July 18, 2006
Last updated: February 12, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Infections, Papillomavirus
Biological: CervarixTM
Biological: HPV investigational vaccine GSK568893A, different formulations
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies. [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    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).

  • Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies. [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.

  • Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.

  • Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies. [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    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.

  • Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies. [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.

  • Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.


Secondary Outcome Measures:
  • Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies. [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    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.

  • Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies. [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.

  • Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies. [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    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.

  • Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies. [ Time Frame: At Months 18, 24, 36 and 48. ] [ Designated as safety issue: No ]
    Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.

  • 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 ] [ Designated as safety issue: No ]
    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)

  • Number of Subjects With at Least One Medically Significant Condition (MAEs). [ Time Frame: From Month 0 to Months 18, 24, 36 and 48 ] [ Designated as safety issue: No ]
    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).

  • Number of Subjects With Any Serious Adverse Events (SAEs). [ Time Frame: From Month 0 to Months 18, 24, 36 and 48 ] [ 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. Any = Occurrence of any symptom regardless of intensity grade.

  • Number of Subjects With Pregnancy Outcomes. [ Time Frame: From Month 0 to Month 18 ] [ Designated as safety issue: No ]
    Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.

  • Number of Subjects With Pregnancy Outcomes. [ Time Frame: From Month 0 to Month 24 ] [ Designated as safety issue: No ]
    Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.

  • Number of Subjects With Pregnancy Outcomes. [ Time Frame: From Month 0 to Month 36 ] [ Designated as safety issue: No ]
    Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.

  • Number of Subjects With Pregnancy Outcomes. [ Time Frame: From Month 0 to Month 48 ] [ Designated as safety issue: No ]
    Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.


Enrollment: 383
Study Start Date: September 2006
Study Completion Date: August 2009
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: CervarixTM
Subjects were administered three doses of HPV vaccine
Experimental: Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Subjects were administered three doses of HPV investigational vaccine
Experimental: Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Subjects were administered three doses of HPV investigational vaccine
Experimental: Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Subjects were administered three doses of HPV investigational vaccine
Experimental: Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Subjects were administered three doses of HPV investigational vaccine
Experimental: Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Subjects were administered three doses of HPV investigational vaccine
Experimental: Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Subjects were administered three doses of HPV investigational vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00359619

Locations
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80262
GSK Investigational Site
Golden, Colorado, United States, 80401
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1070
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Tienen, Belgium, 3300
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00359619     History of Changes
Obsolete Identifiers: NCT00359502, NCT00359528, NCT00359827
Other Study ID Numbers: 108052 (FU month 18)  107919  107921  107918 
Study First Received: July 18, 2006
Results First Received: December 19, 2012
Last Updated: February 12, 2015
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HPV vaccine

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

ClinicalTrials.gov processed this record on August 24, 2016