Clinical Trial Results:
A phase IIIb, open, multi-centre gynaecological extension study for follow-up of a subset of 580299/008 study subjects who were either cervical cytology negative and oncogenic HPV positive or pregnant at their final 580299/008 study visit (Visit 10 at Month 48)
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Summary
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EudraCT number |
2008-008124-33 |
Trial protocol |
FI ES DE GB |
Global end of trial date |
20 Jan 2014
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Results information
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Results version number |
v2(current) |
This version publication date |
02 Nov 2019
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First version publication date |
24 Jan 2015
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
112024
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00937950 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Aug 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Jan 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Jan 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
- To provide clinical management and, if required, treatment to subjects who at the end of the HPV-008 study displayed normal cervical cytology but tested positive for oncogenic HPV infection or to subjects who were pregnant at the end of the HPV-008 study so that no cervical sample could be collected.
- To report fatal serious adverse events (SAEs), SAEs related to study participation and SAEs related to a concurrent GSK medication in all subjects.
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Protection of trial subjects |
As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine in the HPV-008 (NCT00122681) study. For this reason, the vaccinee remained under medical supervision for 30 minutes after vaccination in the HPV-008 (NCT00122681) study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Aug 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 53
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Country: Number of subjects enrolled |
United Kingdom: 42
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Country: Number of subjects enrolled |
Finland: 764
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Country: Number of subjects enrolled |
Germany: 92
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Country: Number of subjects enrolled |
Australia: 49
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Country: Number of subjects enrolled |
Belgium: 13
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Country: Number of subjects enrolled |
Brazil: 211
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Country: Number of subjects enrolled |
Canada: 40
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Country: Number of subjects enrolled |
Italy: 1
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Country: Number of subjects enrolled |
Philippines: 308
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Country: Number of subjects enrolled |
Taiwan: 105
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Country: Number of subjects enrolled |
Thailand: 249
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Country: Number of subjects enrolled |
United States: 95
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Worldwide total number of subjects |
2022
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EEA total number of subjects |
965
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
2022
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
Out of the 2022 subjects enrolled in this study, 19 were excluded for reasons of non-eligibility, hence only 2003 started the study. | ||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
2022 | ||||||||||||||||||
Number of subjects completed |
2003 | ||||||||||||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Subjects not eligible: 19 | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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HPV-052 study subjects Group | ||||||||||||||||||
Arm description |
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit. | ||||||||||||||||||
Arm type |
Gynaecological follow-up (safety data collection) | ||||||||||||||||||
Investigational medicinal product name |
Havrix
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Investigational medicinal product code |
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Other name |
Hepatitis A vaccine
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study.
Subjects received 3 doses of Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.
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Investigational medicinal product name |
Cervarix
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Investigational medicinal product code |
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Other name |
HPV-16/18 L1 VLP AS04
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study.
Subjects received 3 doses of Cervarix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Out of the 2022 subjects enrolled, 19 did not fulfill eligibility criteria and were excluded, hence 2003 subjects started the study. |
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Baseline characteristics reporting groups
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Reporting group title |
HPV-052 study subjects Group
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Reporting group description |
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
HPV-052 study subjects Group
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Reporting group description |
The study group consisted of a subset of HPV-008 (NCT00122681) study subjects (15-25 years old at first study vaccination), who at their last study visit (Visit 10, Month 48) in HPV-008 (NCT00122681) study displayed normal cervical cytology, but were tested positive for oncogenic HPV infection, or were pregnant and hence no cervical sample could be collected at their HPV-008 (NCT00122681) concluding visit. | ||
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End point title |
Number of subjects with HPV DNA in cervical samples by Hybrid Capture 2 test (HCII) [1] | ||||||||||||||||||||||||||||||
End point description |
Subjects who presented oncogenic HPV DNA in cervical samples by HPV DNA testing. The presence of oncogenic HPV infection was determined by the Hybrid Capture 2 (HCII) test, which detects HPV DNA types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68.
Missing = For some of the subjects whose result was indicated as quantity not sufficient (QNS).
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End point type |
Primary
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End point timeframe |
At Months 12, 24, 36, 48
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Number of subjects with colposcopy referral and colposcopy adequacy [2] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Subjects with normal cervical cytology, who were found to be oncogenic HPV DNA positive in two subsequent tests, were referred to colposcopy. The result of the subjects’ last HPV-008 study visit was taken into account at Visit 1. Subjects with a single cervical cytology reading of ≥ atypical squamous cells of undetermined significance (ASC-US) positive for oncogenic HPV DNA were referred for colposcopy. Subjects with a single cervical cytology reading of ≥ low grade squamous intraepithelial lesion (LSIL) were referred to colposcopy, irrespective of their oncogenic HPV DNA test result.
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End point type |
Primary
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End point timeframe |
At Months 12, 24, 36, 48
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with cytological abnormalities in cervical samples by ThinPrep PapTest [3] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology. Cervical cytology examination was performed using the ThinPrep PapTest.
Note: One subject may have presented with different cytology results at the yearly visit throughout the maximum 4-year follow-up period and therefore may be counted in more than one result category in the analysis.
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End point type |
Primary
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End point timeframe |
At Months 12, 24, 36, 48
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with cervical biopsy results at Month 12 [4] | ||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.
Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
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End point type |
Primary
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End point timeframe |
At Month 12
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with cervical biopsy results at Month 24 [5] | ||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.
Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
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End point type |
Primary
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End point timeframe |
At Month 24
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with cervical biopsy results at Month 36 [6] | ||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.
Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
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End point type |
Primary
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End point timeframe |
At Month 36
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with cervical biopsy results at Month 48 [7] | ||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.
CIN = Cervical intraepithelial neoplasia. CIN1/CIN2/CIN3 = Cervical intraepithelial neoplasia grade 1/grade 2/grade 3.
Note: Only CIN1/Only CIN2/Only CIN3 categories contain the subject who has only CIN1/CIN2/CIN3, but not the combinations.
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End point type |
Primary
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End point timeframe |
At Month 48
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with treatment referrals by treatment type at Month 12 [8] | ||||||||||||||||||||||||||||
End point description |
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject’s participation in the study concluded after treatment.
The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
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End point type |
Primary
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End point timeframe |
At Month 12
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Number of subjects with treatment referrals by treatment type at Month 24 [9] | ||||||||||||||||||||||||||||||
End point description |
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject’s participation in the study concluded after treatment.
The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
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End point type |
Primary
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End point timeframe |
At Month 24
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Number of subjects with treatment referrals by treatment type at Month 36 [10] | ||||||||||||||||||||||||||||
End point description |
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject’s participation in the study concluded after treatment.
The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
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End point type |
Primary
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End point timeframe |
At Month 36
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Number of subjects with treatment referrals by treatment type at Month 48 [11] | ||||||||||||||||||||||||||||
End point description |
If a high-grade lesion was detected, the subject was to be referred to treatment according to local medical practice. Any further management following local cervical therapy for cervical lesions was to be handled according to local medical practice within the local health care system. The subject’s participation in the study concluded after treatment.
The treatment types included the following: Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.
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End point type |
Primary
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End point timeframe |
At Month 48
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| Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Number of subjects with adverse events (AEs) or serious adverse events (SAEs) leading to withdrawal [12] | ||||||
End point description |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
|
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End point type |
Primary
|
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End point timeframe |
From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]
|
||||||
| Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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|
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| No statistical analyses for this end point | |||||||
|
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End point title |
Number of subjects with any fatal SAEs, with any SAEs assessed as possibly related to study participation or to a concurrent GSK medication [13] | ||||||||||||
End point description |
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study]
|
||||||||||||
| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||
|
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
AEs and SAEs: From Month 12 [i.e. 12 months after the last visit in HPV-008 (NCT00122681) primary study) up to Month 48 [i.e. 48 months after the last visit in HPV-008 (NCT00122681) primary study].
|
||
Adverse event reporting additional description |
Non-serious AEs were not collected in this study. Only fatal SAEs, SAEs related to study participation, SAEs related to a concurrent GSK medication and AEs and SAEs leading to withdrawal from the study were collected in this study.
|
||
Assessment type |
Non-systematic | ||
|
Dictionary used for adverse event reporting
|
|||
Dictionary name |
MedDRA | ||
Dictionary version |
17.0
|
||
| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Non-serious AEs were not collected in this study. |
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
