Clinical Trial Results:
A long-term, open, follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine in healthy female subjects up to 10 years after administration of the first vaccine dose in study HPV-014
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Summary
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EudraCT number |
2009-011357-41 |
Trial protocol |
DE PL |
Global end of trial date |
03 Feb 2015
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Results information
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Results version number |
v2(current) |
This version publication date |
30 Nov 2020
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First version publication date |
13 Feb 2016
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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 |
112772
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00947115 | ||
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 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, 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 |
11 Dec 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Feb 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Feb 2015
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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 evaluate the long-term immunogenicity of the HPV-16/18 vaccine in serum from all subjects by enzyme-linked immunosorbent assay (ELISA) at Years 5, 6, 7, 8, 9 and 10 following first dose of HPV vaccine.
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Protection of trial subjects |
All subjects were followed up for reporting of vaccine-, study participation-, or GSK concomitant medication-related SAEs and fatal SAEs.
Data were collected and recorded from the time the subject consented to participate in the study until the end of participation in the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Sep 2009
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
6 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Poland: 222
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Country: Number of subjects enrolled |
Germany: 303
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Worldwide total number of subjects |
525
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EEA total number of subjects |
525
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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) |
525
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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 |
This study was conducted at six centers in Germany and Poland. | ||||||||||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Out of the 525 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 524. | ||||||||||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cervarix 15-25 years group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
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). | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Cervarix
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Investigational medicinal product code |
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Other name |
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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 |
No vaccine was administered in this extension study. Blood samples from all subjects, and cervico-vaginal secretion (CVS) samples from subjects who volunteered for this procedure, were collected at each study visit (i.e. at Years 5, 6, 7, 8, 9 and 10). Subjects received 3 doses of Cervarix vaccine administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the primary study HPV-014 (NCT00196937).
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Arm title
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Cervarix 26-45 years group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
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). | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Cervarix
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Investigational medicinal product code |
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Other name |
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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 |
No vaccine was administered in this extension study. Blood samples from all subjects, and cervico-vaginal secretion (CVS) samples from subjects who volunteered for this procedure, were collected at each study visit (i.e. at Years 5, 6, 7, 8, 9 and 10). Subjects received 3 doses of Cervarix vaccine administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the primary study HPV-014 (NCT00196937).
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Arm title
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Cervarix 46-55 years group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
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). | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Cervarix
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Investigational medicinal product code |
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Other name |
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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 |
No vaccine was administered in this extension study. Blood samples from all subjects, and cervico-vaginal secretion (CVS) samples from subjects who volunteered for this procedure, were collected at each study visit (i.e. at Years 5, 6, 7, 8, 9 and 10). Subjects received 3 doses of Cervarix vaccine administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the primary study HPV-014 (NCT00196937).
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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 525 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 524. |
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Baseline characteristics reporting groups
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Reporting group title |
Cervarix 15-25 years group
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Reporting group description |
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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cervarix 26-45 years group
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Reporting group description |
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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cervarix 46-55 years group
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Reporting group description |
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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cervarix 15-25 years group
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Reporting group description |
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). | ||
Reporting group title |
Cervarix 26-45 years group
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Reporting group description |
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). | ||
Reporting group title |
Cervarix 46-55 years group
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Reporting group description |
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). | ||
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End point title |
Anti-Human Papillomavirus (Anti-HPV)-16/18 antibody titers in serum at years 5, 6 and 7 [1] | ||||||||||||||||||||||||||||||||||||||||
End point description |
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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End point type |
Primary
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End point timeframe |
At Years 5, 6 and 7
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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 |
Anti-HPV-16/18 antibody titers in serum at years 8, 9 and 10 [2] | ||||||||||||||||||||||||||||||||||||||||
End point description |
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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End point type |
Primary
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End point timeframe |
At Years 8, 9 and 10
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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 seroconverted subjects for anti-HPV-16 and anti-HPV-18 antibodies at years 5, 6 and 7 [3] | ||||||||||||||||||||||||||||||||||||
End point description |
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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End point type |
Primary
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End point timeframe |
At Years 5, 6 and 7
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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 seroconverted subjects for anti-HPV-16 and anti-HPV-18 antibodies at years 8, 9 and 10 [4] | ||||||||||||||||||||||||||||||||||||
End point description |
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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End point type |
Primary
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End point timeframe |
At Years 8, 9 and 10
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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 |
Anti-HPV-16/18 secretion antibody titers in cervico-vaginal secretion (CVS) samples at Years 5 and 6 in a subset of subjects | ||||||||||||||||||||||||||||||||
End point description |
Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
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End point type |
Secondary
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End point timeframe |
At Year 5 and Year 6
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Anti-HPV-16/18 secretion antibody titers in CVS samples at Years 7, 8, 9 and 10 in a subset of subjects | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.
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End point type |
Secondary
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End point timeframe |
At Years 7, 8, 9 and 10
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Total Immunoglobulin G (IgG) secretion antibody titers in CVS samples at Years 5 and 6 in a subset of subjects | ||||||||||||||||||||||||
End point description |
IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
At Year 5 and Year 6
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Total IgG secretion antibody titers in CVS samples at Years 7, 8, 9, and 10 in a subset of subjects | ||||||||||||||||||||||||||||||||
End point description |
Total IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
At Years 7, 8, 9 and 10
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Total IgG antibody titers in serum at Years 5, 6 and 7 based on the ATP cohort for immunogenicity | ||||||||||||||||||||||||||||
End point description |
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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End point type |
Secondary
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End point timeframe |
At Years 5, 6 and 7
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Total IgG antibody titers in serum at Years 8, 9 and 10 based on the ATP cohort for immunogenicity | ||||||||||||||||||||||||||||
End point description |
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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End point type |
Secondary
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End point timeframe |
At Years 8, 9 and 10
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Total IgG antibody titers in serum at Years 5, 6 and 7 based on the TVC | ||||||||||||||||||||||||||||
End point description |
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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End point type |
Secondary
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End point timeframe |
At Years 5, 6 and 7
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Total IgG antibody titers in serum at Years 8, 9 and 10 based on the TVC | ||||||||||||||||||||||||||||
End point description |
Total IgG antibody titers are presented as GMTs and expressed in µg/mL.
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||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
At Years 8, 9 and 10
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
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 | ||||||||||||||||||||
End point description |
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).
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 study
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
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 | ||||||||||||||||||||
End point description |
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).
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
From Year 5 up to Year 6
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
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 | ||||||||||||||||||||
End point description |
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).
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
From Year 6 up to Year 7
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
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 | ||||||||||||||||||||
End point description |
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).
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
From Year 7 up to Year 8
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
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 | ||||||||||||||||||||
End point description |
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).
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
From Year 8 up to Year 9
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
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 | ||||||||||||||||||||
End point description |
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).
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
From Year 9 up to Year 10
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
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 | ||||||||||||||||||||
End point description |
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).
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
From Year 0 up to Year 10
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
SAEs: Throughout the entire study period (from Year 0 up to the Year 10).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
|
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|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cervarix 15-25 years group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cervarix 46-55 years group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cervarix 26-45 years group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 adverse events were not collected in this study. |
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|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
02 Dec 2013 |
• The assay used to measure anti-HPV-16/-18 antibody concentrations at the designated laboratory was improved to increase the assay precision by changing the assay cut-off value from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18.
• The IgG ELISA assay was replaced by IgG nephelometry assay to measure total IgG in the serum matrix because the assay output of nephelometry was proven less variable than that of ELISA. |
||
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 | |||
