Clinical Trial Results:
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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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 |
v1 |
This version publication date |
13 Feb 2016
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First version publication date |
13 Feb 2016
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Other versions |
v2 |
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 |
Interim
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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.
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Protection of trial subjects |
All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
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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 |
- | ||||||||||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Some subjects who came for the Year 5 timepoint did not show up for the Year 6, 7, 8 or 9 timepoints, hence the numbers of subjects starting each year do not correspond to the ones of the previous years. | ||||||||||||||||||||||||||||||||||||||||
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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 (NCT00196937) | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
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 |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
All subjects received 3 doses of HPV vaccine administered intramuscularly
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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 (NCT00196937) | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
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 |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
All subjects received 3 doses of HPV vaccine administered intramuscularly
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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 (NCT00196937) | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
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 |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
All subjects received 3 doses of HPV vaccine administered intramuscularly
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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: Some subjects participating in study HPV-014 (103514) did not consent or were not selected to take part in the current study, HPV-060 (112772). |
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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 (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 (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 (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 (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 (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 (NCT00196937) | ||
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End point title |
Anti-Human Papillomavirus (Anti-HPV) 16/18 antibody titers in serum [1] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
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End point type |
Primary
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End point timeframe |
At Year 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: This was a descriptive analysis, hence no statistical methods were required. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of seroconverted subjects. [2] | ||||||||||||||||||||||||||||||||||||
End point description |
Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 8 and 7 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.
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End point type |
Primary
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End point timeframe |
At Year 5, 6 and 7
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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: This was a descriptive analysis, hence no statistical methods were required. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Number of seroconverted subjects. [3] | ||||||||||||||||||||||||||||||||||||
End point description |
Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.
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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 [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: This was a descriptive analysis, hence no statistical methods were required. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Anti-Human Papillomavirus (Anti-HPV) 16/18 antibody titers in serum [4] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
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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: This was a descriptive analysis, hence no statistical methods were required. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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End point title |
Total Immunoglobulin G (IgG) antibody titers in serum | ||||||||||||||||||||||||||||
End point description |
IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
At Year 5, 6 and 7
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Total Immunoglobulin G (IgG) antibody titers in serum | ||||||||||||||||||||||||||||
End point description |
IgG antibody titers were expressed as GMTs in microgram per milliliter (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 |
Anti-HPV-16/18 secretion antibody titers in cervico-vaginal secretion (CVS) | ||||||||||||||||||||||||||||||||
End point description |
Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (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 cervico-vaginal secretion (CVS) | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).
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End point type |
Secondary
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End point timeframe |
At Years 7, 8, 9, 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 | ||||||||||||||||||||||||
End point description |
Titers were given as GMTs 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 Immunoglobulin G (IgG) secretion antibody titers in CVS | ||||||||||||||||||||||||||||||||
End point description |
Titers were given as GMTs 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, 10
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Total Immunoglobulin G (IgG) antibody titers in serum | ||||||||||||||||||||||||||||
End point description |
IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
At Year 5, 6 and 7
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Total Immunoglobulin G (IgG) antibody titers in serum | ||||||||||||||||||||||||||||
End point description |
IgG antibody titers were expressed as GMTs in microgram per milliliter (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 |
Number of subjects with any fatal or vaccine-related serious adverse events (SAEs) (including SAEs related to study procedures and GlaxoSmithKline Biologicals' concomitant medication). | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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End point type |
Secondary
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End point timeframe |
From Month 48 in primary study (NCT00196937) up to Month 60 (Year 5)
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of subjects with any fatal or vaccine-related serious adverse events (SAEs) (including SAEs related to study procedures and GlaxoSmithKline Biologicals' concomitant medication). | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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End point type |
Secondary
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End point timeframe |
From the Month 60 (Year 5) visit until the Month 72 (Year 6) visit
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of subjects with any fatal or vaccine-related serious adverse events (SAEs) (including SAEs related to study procedures and GlaxoSmithKline Biologicals' concomitant medication). | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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End point type |
Secondary
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End point timeframe |
From Month 72 (Year 6) visit to Month 84 (Year 7) visit
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of subjects with any fatal or vaccine-related serious adverse events (SAEs) (including SAEs related to study procedures and GlaxoSmithKline Biologicals' concomitant medication). | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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End point type |
Secondary
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End point timeframe |
From Month 84 (Year 7) to the Month 96 (Year 8) visit
|
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of subjects with any fatal or vaccine-related serious adverse events (SAEs) (including SAEs related to study procedures and GlaxoSmithKline Biologicals' concomitant medication). | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
|
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End point type |
Secondary
|
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End point timeframe |
From Month 96 (Year 8) to the Month 108 (Year 9) visit
|
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|
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| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Number of subjects with any fatal or vaccine-related serious adverse events (SAEs) (including SAEs related to study procedures and GlaxoSmithKline Biologicals' concomitant medication). | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
|
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End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Year 0 up to Year 10
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Number of subjects with any fatal or vaccine-related serious adverse events (SAEs) (including SAEs related to study procedures and GlaxoSmithKline Biologicals' concomitant medication) | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Month 108 (Year 9) to the Month 120 (Year 10) visit
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information [1]
|
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Timeframe for reporting adverse events |
SAEs: throughout the entire study from Day 0 up to the Year 10 visit.
|
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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 study NCT00196937, i.e. excluding those who were not selected or not consented for HPV-060.
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
|
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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 (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 (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 (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: No non-serious AEs were reported for this trial. |
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|
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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|
|||
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 will be 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 | |||
