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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:
ClinicalTrials.gov Identifier:
NCT00947115
First Posted: July 27, 2009
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
July 16, 2009
July 27, 2009
February 10, 2011
May 2, 2011
February 23, 2017
September 2009
February 2015   (Final data collection date for primary outcome measure)
  • 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.
Evaluation of immune response to components of the vaccine in serum of all subjects following first dose of GSK 580299 vaccine [ Time Frame: Years 5, 6, 7, 8, 9 and 10 ]
Complete list of historical versions of study NCT00947115 on ClinicalTrials.gov Archive Site
  • 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.
  • Evaluation of immune response to components of the vaccine in cervico-vaginal samples (CVS) of subjects who volunteer following first dose of GSK 580299 vaccine [ Time Frame: Years 5, 6, 7, 8, 9 and 10 ]
  • Evaluation of immune response to components of the vaccine in serum from efficacy studies NCT00689741, NCT00120848, NCT00518336 [ Time Frame: Years 5, 6, 7, 8, 9 and 10 ]
  • Evaluation of immune response to components of the vaccine in serum elicited after natural infection (NCT00122681) [ Time Frame: Years 5, 6, 7, 8, 9 and 10 ]
  • Evaluation of immune response in serum from subjects who volunteer following first dose of GSK 580299 vaccine [ Time Frame: Years 5, 6, 7, 8, 9 and 10 ]
  • Occurrence of vaccine-related SAEs (including SAEs related to study procedures and GSK Biological concomitant medication). [ Time Frame: Throughout the study period ]
Not Provided
Not Provided
 
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects
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).

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Infections, Papillomavirus
  • 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 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)
    Interventions:
    • Procedure: Blood sampling
    • Procedure: Cervico-vaginal secretion (CVS) samples
  • 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)
    Interventions:
    • Procedure: Blood sampling
    • Procedure: Cervico-vaginal secretion (CVS) samples
  • 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)
    Interventions:
    • Procedure: Blood sampling
    • Procedure: Cervico-vaginal secretion (CVS) samples
Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Gałaj A, Schulze K, Suryakiran P, Thomas F, Descamps D. Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study. BJOG. 2015 Jan;122(1):107-18. doi: 10.1111/1471-0528.13070. Epub 2014 Sep 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
525
February 2015
February 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
20 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany,   Poland
 
 
NCT00947115
112772
Not Provided
Not Provided
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP