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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00947115
Registration number
NCT00947115
Ethics application status
Date submitted
16/07/2009
Date registered
27/07/2009
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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0
2009-011357-41
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Secondary ID [2]
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0
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:
Advanced Solid Tumors
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0
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Infections, Papillomavirus
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0
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
0
0
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Cystic fibrosis
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Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
0
0
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Connective tissue diseases
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Metabolic and Endocrine
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0
0
0
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Diabetes
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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
Treatment: Drugs - CP-868,596
Treatment: Drugs - Docetaxel
Treatment: Drugs - CP-868,596
Treatment: Drugs - Docetaxel
Treatment: Drugs - CP-868,596
Treatment: Drugs - Docetaxel
Treatment: Drugs - CP-868,596
Treatment: Drugs - AG-013736
Treatment: Drugs - Docetaxel
Treatment: Drugs - GS-9411
Treatment: Drugs - Placebo
Treatment: Drugs - vemurafenib
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).
Experimental: Cohort 1 - 60 mg BID/ 75 mg/m2
Experimental: Cohort 2 - 100 mg BID/75 mg/m2
Experimental: Cohort 3 - 100 mg BID/100 mg/m2
Experimental: Cohort 4b - CP-868,596 + AG-013736 + TXT 75
Placebo comparator: 5 - Placebo
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.
Treatment: Drugs: CP-868,596
Oral tablet 60 mg BID continuous
Treatment: Drugs: Docetaxel
Intravenous 75 mg/m2 every three weeks
Treatment: Drugs: CP-868,596
Oral tablet 100 mg BID continuous
Treatment: Drugs: Docetaxel
Intravenous 75 mg/m2 every three weeks
Treatment: Drugs: CP-868,596
Oral tablet 100 mg BID continuous
Treatment: Drugs: Docetaxel
Intravenous 100 mg/m2 every three weeks
Treatment: Drugs: CP-868,596
Oral tablet 60 mg BID continuous
Treatment: Drugs: AG-013736
Oral tablet 5 mg BID continuous
Treatment: Drugs: Docetaxel
Intravenous 75 mg/m2 every three weeks
Treatment: Drugs: GS-9411
Inhaled GS-9411 dissolved in sterile saline
Treatment: Drugs: Placebo
Inhaled placebo in sterile saline
Treatment: Drugs: vemurafenib
960 mg b.i.d. continuous oral dosing
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Drugs
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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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Primary outcome [5]
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First-cycle Dose Limiting Toxicities
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Assessment method [5]
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0
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Timepoint [5]
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2.5 years
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Primary outcome [6]
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Safety and Tolerability of 4 escalating doses of GS-9411 in healthy male volunteers
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Assessment method [6]
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0
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Timepoint [6]
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7 Days
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Primary outcome [7]
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Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
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Assessment method [7]
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BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
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Timepoint [7]
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From first treatment through September 27, 2010
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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]
0
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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]
0
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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]
0
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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]
0
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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]
0
0
At Years 5, 6 and 7
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Secondary outcome [8]
0
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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]
0
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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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0
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]
0
0
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]
0
0
From Year 5 up to Year 6
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Secondary outcome [11]
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0
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]
0
0
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]
0
0
From Year 6 up to Year 7
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Secondary outcome [12]
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0
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]
0
0
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]
0
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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]
0
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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]
0
0
From Year 8 up to Year 9
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Secondary outcome [14]
0
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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]
0
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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]
0
0
From Year 9 up to Year 10
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Secondary outcome [15]
0
0
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]
0
0
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]
0
0
From Year 0 up to Year 10
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Secondary outcome [16]
0
0
Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule
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Assessment method [16]
0
0
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Timepoint [16]
0
0
2.5 years
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Secondary outcome [17]
0
0
Determine the safety and tolerability of the combination of daily CP-868,596 plus daily AG-013736 plus docetaxel on an every 3-week schedule
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Assessment method [17]
0
0
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Timepoint [17]
0
0
2.5 years
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Secondary outcome [18]
0
0
To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination
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Assessment method [18]
0
0
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Timepoint [18]
0
0
2.5 years
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Secondary outcome [19]
0
0
To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination
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Assessment method [19]
0
0
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Timepoint [19]
0
0
2.5 years
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Secondary outcome [20]
0
0
Conduct biomarker investigations on plasma/serum samples to explore critical events in pharmacodynamic response to CP-868,596 (eg, VEGF, phospho-SHP, etc.)
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Assessment method [20]
0
0
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Timepoint [20]
0
0
2.5 years
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Secondary outcome [21]
0
0
To explore the relationship between polymorphisms in genes involved in the metabolism and transport of CP-868,596 and pharmacokinetic/pharmacodynamic parameters
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Assessment method [21]
0
0
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Timepoint [21]
0
0
2.5 years
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Secondary outcome [22]
0
0
To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI
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Assessment method [22]
0
0
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Timepoint [22]
0
0
2.5 years
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Secondary outcome [23]
0
0
To assess any preliminary clinical evidence of anti-tumor activity using RECIST
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Assessment method [23]
0
0
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Timepoint [23]
0
0
2.5 years
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Secondary outcome [24]
0
0
Decrease in mean Fasting Plasma Glucose (FPG)
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Assessment method [24]
0
0
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Timepoint [24]
0
0
At week 24
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Secondary outcome [25]
0
0
Mean change in body weight
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Assessment method [25]
0
0
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Timepoint [25]
0
0
At week 24
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Secondary outcome [26]
0
0
Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
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Assessment method [26]
0
0
BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
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Timepoint [26]
0
0
From first treatment through September 27, 2010
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Secondary outcome [27]
0
0
Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
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Assessment method [27]
0
0
Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.
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Timepoint [27]
0
0
From first treatment through September 27, 2010
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Secondary outcome [28]
0
0
Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
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Assessment method [28]
0
0
Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.
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Timepoint [28]
0
0
From first treatment through September 27, 2010
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Secondary outcome [29]
0
0
Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
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Assessment method [29]
0
0
PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.
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Timepoint [29]
0
0
From first treatment through September 27, 2010
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Secondary outcome [30]
0
0
Overall Survival
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Assessment method [30]
0
0
Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.
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Timepoint [30]
0
0
From first treatment through September 27, 2010
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Secondary outcome [31]
0
0
Improvement in Physical Symptoms (Improvement in Physician's Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline
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Assessment method [31]
0
0
Three parameters were measured. (1) Improvement in the Physician's Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value \< 95% to = 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.
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Timepoint [31]
0
0
From first treatment through September 27, 2010
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Secondary outcome [32]
0
0
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1
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Assessment method [32]
0
0
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).
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Timepoint [32]
0
0
Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
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Secondary outcome [33]
0
0
Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1
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Assessment method [33]
0
0
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.
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Timepoint [33]
0
0
Pre-dose to 8 hours post-dose on Day 15 of Cycle 1
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Secondary outcome [34]
0
0
Vemurafenib Plasma Levels at Various Treatment Cycles
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Assessment method [34]
0
0
Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.
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Timepoint [34]
0
0
Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1
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Secondary outcome [35]
0
0
Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)
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Assessment method [35]
0
0
Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)\^ß (ß=mean \[calculated separately for males and females\] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.
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Timepoint [35]
0
0
Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1
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Secondary outcome [36]
0
0
Percentage of Patients With Adverse Event
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Assessment method [36]
0
0
The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).
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Timepoint [36]
0
0
From first treatment through September 27, 2010
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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)
VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - East Melbourne
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Recruitment hospital [2]
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Nucleus Network, Ltd. - Melbourne
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Recruitment hospital [3]
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Sanofi-Aventis Administrative Office - Macquarie Park
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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- Macquarie Park
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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]
0
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Poland
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State/province [4]
0
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Poznan
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Country [5]
0
0
United States of America
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State/province [5]
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North Carolina
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Country [6]
0
0
United States of America
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State/province [6]
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California
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Country [7]
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United States of America
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State/province [7]
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Colorado
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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/study/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
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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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0
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
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Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=4512
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00947115