Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00877877
First received: March 26, 2009
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives & outcome measures of the extension phase from Month 60 to Month 120. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).


Condition Intervention Phase
Infections, Papillomavirus
Procedure: Blood sampling
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (580299) in Healthy Female Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. [ Time Frame: At Month 60 ] [ Designated as safety issue: No ]

    Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.

    Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

    A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.

    A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.


  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. [ Time Frame: At Month 72 ] [ Designated as safety issue: No ]

    Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.

    Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

    A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.

    A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.


  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. [ Time Frame: At Month 84 ] [ Designated as safety issue: No ]

    Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.

    Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

    A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.

    A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.


  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. [ Time Frame: At Month 96 ] [ Designated as safety issue: No ]

    Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.

    Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

    A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.

    A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.


  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers [ Time Frame: At Month 60 ] [ Designated as safety issue: No ]
    Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).

  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers [ Time Frame: At month 72 ] [ Designated as safety issue: No ]
    Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).

  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers [ Time Frame: At Month 84 ] [ Designated as safety issue: No ]
    Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).

  • Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values. [ Time Frame: At Months108 and 120 ] [ Designated as safety issue: No ]
  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers [ Time Frame: At Month 96 ] [ Designated as safety issue: No ]
    Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).

  • Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers [ Time Frame: At Months108 and 120 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Month 48 to Month 60 ] [ 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 With Serious Adverse Events (SAEs) [ Time Frame: From Month 72 to Month 84 ] [ 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 With Serious Adverse Events (SAEs) [ Time Frame: From Month 60 to Month 72 ] [ 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 With Serious Adverse Events (SAEs) [ Time Frame: From Month 84 to Month 96 ] [ 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.

  • Anti-HPV-16/18 Antibody Titers in Efficacy Studies NCT00689741/NCT00120848/NCT00518336 [ Time Frame: At Months 60, 72, 84, 96, 108 and 120 ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values in Efficacy Studies NCT00689741/NCT00120848/NCT00518336 [ Time Frame: At Months 60, 72, 84, 96, 108 and 120 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 Antibody Titers Elicited After Natural Infection (Study 580299/008 (NCT00122681)) [ Time Frame: At Month 0 ] [ Designated as safety issue: No ]
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Month 48 to Month 120 ] [ Designated as safety issue: No ]

Enrollment: 529
Study Start Date: May 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Procedure: Blood sampling
Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120

Detailed Description:

Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study.

Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013.
  • Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject.

Exclusion Criteria:

  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
  • Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013.
  • Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry.
  • Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.
  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: NCT00877877

Locations
Colombia
GSK Investigational Site
Bogota, Colombia
Germany
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
GSK Investigational Site
Weilheim, Bayern, Germany, 82362
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18109
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Harrislee, Schleswig-Holstein, Germany, 24955
GSK Investigational Site
Niebuell, Schleswig-Holstein, Germany, 25899
GSK Investigational Site
Weimar, Thueringen, Germany, 99425
GSK Investigational Site
Berlin, Germany, 10967
GSK Investigational Site
Berlin, Germany, 10315
GSK Investigational Site
Hamburg, Germany, 22307
Honduras
GSK Investigational Site
Tegucigalpa, Francisco Morazan, Honduras, 11101
Panama
GSK Investigational Site
Arraijan/Vista Alegre, Panamá, Panama
GSK Investigational Site
La Chorrera, Panamá, Panama
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taoyuan, Taiwan, 333
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00877877     History of Changes
Other Study ID Numbers: 111375
Study First Received: March 26, 2009
Results First Received: March 31, 2011
Last Updated: July 22, 2014
Health Authority: Colombia: INVIMA
Taiwan: Department of Health
Honduras: UNAH
Panama: Instituto Conmemorativo Gorgas de Estudios de la Salud. Comité Nacional de Bioética de la Investigación
Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
HPV vaccine
cervical cancer

ClinicalTrials.gov processed this record on October 23, 2014