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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/NCT00877877
Registration number
NCT00877877
Ethics application status
Date submitted
26/03/2009
Date registered
8/04/2009
Date last updated
18/01/2020
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 a HPV Vaccine (GSK 580299) in Healthy Female Subjects
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Secondary ID [1]
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0
2008-000369-44
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Secondary ID [2]
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111375
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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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0
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Papillomavirus Vaccines
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0
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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
Other: Cervarix Group - Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Treatment: Surgery: Blood sampling
Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120
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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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Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
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Assessment method [1]
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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.
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Timepoint [1]
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At Month 60
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Primary outcome [2]
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Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
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Assessment method [2]
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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.
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Timepoint [2]
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At Month 72
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Primary outcome [3]
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Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
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Assessment method [3]
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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.
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Timepoint [3]
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At Month 84
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Primary outcome [4]
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Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
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Assessment method [4]
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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.
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Timepoint [4]
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At Month 96
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Primary outcome [5]
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Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
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Assessment method [5]
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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).
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Timepoint [5]
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At Month 60
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Primary outcome [6]
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Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
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Assessment method [6]
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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).
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Timepoint [6]
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At month 72
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Primary outcome [7]
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Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
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Assessment method [7]
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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).
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Timepoint [7]
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At Month 84
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Primary outcome [8]
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Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
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Assessment method [8]
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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).
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Timepoint [8]
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At Month 96
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Primary outcome [9]
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Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
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Assessment method [9]
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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.
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Timepoint [9]
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At Month 108
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Primary outcome [10]
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Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
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Assessment method [10]
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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).
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Timepoint [10]
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At Month 108
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Primary outcome [11]
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Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
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Assessment method [11]
0
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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.
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Timepoint [11]
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At Month 120
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Primary outcome [12]
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Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
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Assessment method [12]
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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.
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Timepoint [12]
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At Month 120
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Secondary outcome [1]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [1]
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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.
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Timepoint [1]
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From Month 48 to Month 60
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Secondary outcome [2]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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From Month 60 to Month 72
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Secondary outcome [3]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [3]
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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.
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Timepoint [3]
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From Month 72 to Month 84
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Secondary outcome [4]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [4]
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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.
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Timepoint [4]
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From Month 84 to Month 96
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Secondary outcome [5]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [5]
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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.
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Timepoint [5]
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From Month 96 to Month 108
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Secondary outcome [6]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [6]
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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.
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Timepoint [6]
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From Month 108 to Month 120
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Eligibility
Key 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.
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Minimum age
15
Years
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Maximum age
24
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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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
Single group
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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
7/05/2009
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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
6/01/2015
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Sample size
Target
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Accrual to date
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Final
632
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Colombia
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State/province [1]
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Bogota
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Country [2]
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Germany
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State/province [2]
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Baden-Wuerttemberg
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Country [3]
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Germany
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State/province [3]
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Bayern
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Country [4]
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Germany
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State/province [4]
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Mecklenburg-Vorpommern
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Country [5]
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Germany
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State/province [5]
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Niedersachsen
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Country [6]
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Germany
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State/province [6]
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Nordrhein-Westfalen
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Country [7]
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Germany
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State/province [7]
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Rheinland-Pfalz
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Country [8]
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Germany
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State/province [8]
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Schleswig-Holstein
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Country [9]
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Germany
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State/province [9]
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Thueringen
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Country [10]
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Germany
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State/province [10]
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Berlin
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Country [11]
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Germany
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State/province [11]
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Hamburg
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Country [12]
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0
Honduras
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State/province [12]
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Francisco Morazan
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Country [13]
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Panama
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State/province [13]
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Panamá
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Country [14]
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0
Panama
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State/province [14]
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La Chorrera
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Country [15]
0
0
Taiwan
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State/province [15]
0
0
Taipei
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Country [16]
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0
Taiwan
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State/province [16]
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Taoyuan
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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 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00877877
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Trial related presentations / publications
Schwarz TF, Huang LM, Lin TY, Wittermann C, Panzer F, Valencia A, Suryakiran PV, Lin L, Descamps D. Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial. Pediatr Infect Dis J. 2014 Dec;33(12):1255-61. doi: 10.1097/INF.0000000000000460.
Schwarz TF, Huang LM, Valencia A, Panzer F, Chiu CH, Decreux A, Poncelet S, Karkada N, Folschweiller N, Lin L, Dubin G, Struyf F. A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years. Hum Vaccin Immunother. 2019;15(7-8):1970-1979. doi: 10.1080/21645515.2019.1625644. Epub 2019 Jul 17.
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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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0
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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/NCT00877877
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