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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00947115
First received: July 16, 2009
Last updated: January 9, 2017
Last verified: January 2017
  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 GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT 00196937. This protocol posting deals with objectives & outcome measures of the extension phase from Year 5 to Year 10. The objectives & outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT 00196937).

Condition Intervention Phase
Infections, Papillomavirus Procedure: Blood sampling Procedure: Cervico-vaginal secretion (CVS) samples Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum [ Time Frame: At Year 5, 6 and 7 ]
    Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).

  • Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum [ Time Frame: At Years 8, 9 and 10 ]
    Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.

  • Number of Seroconverted Subjects. [ Time Frame: At Year 5, 6 and 7 ]
    Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 8 and 7 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.

  • Number of Seroconverted Subjects. [ Time Frame: At Years 8, 9 and 10 ]
    Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.


Secondary Outcome Measures:
  • Total Immunoglobulin G (IgG) Antibody Titers in Serum [ Time Frame: At Year 5, 6 and 7 ]
    IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).

  • Total Immunoglobulin G (IgG) Antibody Titers in Serum [ Time Frame: At Years 8, 9 and 10 ]
    IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).

  • Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) [ Time Frame: At Year 5 and Year 6 ]
    Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).

  • Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) [ Time Frame: At Years 7, 8, 9, 10 ]
    Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).

  • Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS [ Time Frame: At Year 5 and Year 6 ]
    Titers were given as GMTs expressed in microgram per milliliter (µg/mL).

  • Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS [ Time Frame: At Years 7, 8, 9, 10 ]
    Titers were given as GMTs expressed in microgram per milliliter (µg/mL)

  • Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From Month 48 in primary study (NCT00196937) up to Month 60 (Year 5) ]
    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 Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From the Month 60 (Year 5) visit until the Month 72 (Year 6) visit ]
    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 Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From Month 72 (Year 6) visit to Month 84 (Year 7) visit ]
    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 Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From Month 84 (Year 7) to the Month 96 (Year 8) visit ]
    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 Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From Month 96 (Year 8) to the Month 108 (Year 9) visit ]
    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 Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) [ Time Frame: From Month 108 (Year 9) to the Month 120 (Year 10) visit ]
    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 Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication). [ Time Frame: From Year 0 up to Year 10 ]
    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.


Enrollment: 525
Study Start Date: September 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix 15-25 years group
Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Procedure: Blood sampling
Blood samples will be collected at Years 5, 6, 7, 8, 9 and 10
Procedure: Cervico-vaginal secretion (CVS) samples
CVS will be collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteer for this procedure.
Experimental: Cervarix 26-45 years group
Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Procedure: Blood sampling
Blood samples will be collected at Years 5, 6, 7, 8, 9 and 10
Procedure: Cervico-vaginal secretion (CVS) samples
CVS will be collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteer for this procedure.
Experimental: Cervarix 46-55 years group
Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
Procedure: Blood sampling
Blood samples will be collected at Years 5, 6, 7, 8, 9 and 10
Procedure: Cervico-vaginal secretion (CVS) samples
CVS will be collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteer for this procedure.

Detailed Description:

Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). 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:   20 Years to 60 Years   (Adult)
Sexes 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.
  • A female who enrolled in NCT00332475 and received three doses of GSK 580299 vaccine.
  • Written informed consent obtained from the subject.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
  • Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
  • 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 (pharmaceutical product or device).
  • Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
  • Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in NCT00332475 study.
  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: NCT00947115

Locations
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80637
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Berlin, Germany, 12200
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-079
GSK Investigational Site
Poznan, Poland, 60-535
GSK Investigational Site
Poznan, Poland, 61-709
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112772
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112772
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112772
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112772
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112772
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00947115     History of Changes
Other Study ID Numbers: 112772
Study First Received: July 16, 2009
Results First Received: February 10, 2011
Last Updated: January 9, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Cervical cancer
HPV vaccine

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

ClinicalTrials.gov processed this record on June 26, 2017