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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00947115
Registration number
NCT00947115
Ethics application status
Date submitted
16/07/2009
Date registered
27/07/2009
Date last updated
30/10/2020
Titles & IDs
Public title
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
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Scientific title
Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects
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Secondary ID [1]
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2009-011357-41
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Secondary ID [2]
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112772
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infections, Papillomavirus
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Blood sampling
Treatment: Surgery - Cervico-vaginal secretion (CVS) samples
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 HPV-014 (NCT00196937).
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 HPV-014 (NCT00196937).
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 HPV-014 (NCT00196937).
Treatment: Surgery: Blood sampling
Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.
Treatment: Surgery: Cervico-vaginal secretion (CVS) samples
CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7
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Assessment method [1]
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Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008.
The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT record NCT00518336. The immune response data for the HPV-008 study can be found under the NCT record NCT00122681.
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Timepoint [1]
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At Years 5, 6 and 7
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Primary outcome [2]
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Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10
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Assessment method [2]
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Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.
The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008.
The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT number NCT00518336. The immune response data for the HPV-008 study can be found under the NCT number NCT00122681.
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Timepoint [2]
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At Years 8, 9 and 10
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Primary outcome [3]
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Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7
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Assessment method [3]
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Seroconversion was defined as the appearance of anti-HPV-16 and anti- HPV-18 antibodies [i.e. antibody titer greater than or equal to (=) the cut-off value] in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibody titers and 7 EL.U/mL for anti-HPV-18 antibody titers.
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Timepoint [3]
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At Years 5, 6 and 7
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Primary outcome [4]
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Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10
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Assessment method [4]
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Seroconversion was defined as the appearance of anti-HPV-16 and anti-HPV-18 antibodies (i.e. antibody titer = the cut-off value) in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 19 EL.U/mL for anti-HPV-16 antibody titers and 18 EL.U/mL for anti-HPV-18 antibody titers.
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Timepoint [4]
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At Years 8, 9 and 10
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Secondary outcome [1]
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Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects
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Assessment method [1]
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Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
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Timepoint [1]
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At Year 5 and Year 6
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Secondary outcome [2]
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Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects
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Assessment method [2]
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Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
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Timepoint [2]
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At Years 7, 8, 9 and 10
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Secondary outcome [3]
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Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects
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Assessment method [3]
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IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
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Timepoint [3]
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At Year 5 and Year 6
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Secondary outcome [4]
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Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects
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Assessment method [4]
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Total IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
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Timepoint [4]
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At Years 7, 8, 9 and 10
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Secondary outcome [5]
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Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity
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Assessment method [5]
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Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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Timepoint [5]
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At Years 5, 6 and 7
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Secondary outcome [6]
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Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity
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Assessment method [6]
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Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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Timepoint [6]
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At Years 8, 9 and 10
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Secondary outcome [7]
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Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC
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Assessment method [7]
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Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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Timepoint [7]
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At Years 5, 6 and 7
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Secondary outcome [8]
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Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC
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Assessment method [8]
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Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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Timepoint [8]
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At Years 8, 9 and 10
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Secondary outcome [9]
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Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study
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Assessment method [9]
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SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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Timepoint [9]
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From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 study
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Secondary outcome [10]
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Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6
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Assessment method [10]
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SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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Timepoint [10]
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From Year 5 up to Year 6
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Secondary outcome [11]
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Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7
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Assessment method [11]
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SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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Timepoint [11]
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From Year 6 up to Year 7
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Secondary outcome [12]
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Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8
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Assessment method [12]
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SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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Timepoint [12]
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From Year 7 up to Year 8
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Secondary outcome [13]
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Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9
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Assessment method [13]
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SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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Timepoint [13]
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From Year 8 up to Year 9
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Secondary outcome [14]
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Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10
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Assessment method [14]
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SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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Timepoint [14]
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From Year 9 up to Year 10
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Secondary outcome [15]
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Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10
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Assessment method [15]
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SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).
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Timepoint [15]
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From Year 0 up to Year 10
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Eligibility
Key inclusion criteria
- Subjects who the investigator believed that they could and would comply with the
requirements of the protocol.
- A female who had been enrolled in NCT00196937 study and received three doses of
HPV-16/18 vaccine.
- Written informed consent obtained from the subject.
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Minimum age
20
Years
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Maximum age
60
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key 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 NCT00196937 study.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/09/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/02/2015
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Sample size
Target
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Accrual to date
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Final
525
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Bayern
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Country [2]
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Germany
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State/province [2]
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Berlin
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Country [3]
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Poland
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State/province [3]
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Bydgoszcz
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Country [4]
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Poland
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State/province [4]
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Poznan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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 NCT00196937. 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 (NCT00196937).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00947115
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Trial related presentations / publications
Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Galaj 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.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00947115
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