Clinical Trial Results:
A phase IIIb, open-label, non-randomised, multicentre study to assess the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to a 2-dose schedule in healthy female adolescents or intramuscularly according to a 3-dose schedule in healthy female adults, 6.5 years after first vaccine dose in study HPV-048 PRI (110659).
Summary
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EudraCT number |
2014-000060-17 |
Trial protocol |
DE |
Global end of trial date |
29 Jul 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Dec 2018
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First version publication date |
22 Dec 2018
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Other versions |
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Summary report(s) |
Cancelled before Active Statement (2014-000060-17) |
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 |
200255
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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, +44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, +44 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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Jul 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Jul 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess the persistence of anti-HPV-16 and anti-HPV-18 antibodies [by Enzyme Linked Immunosorbent assay (ELISA)] in subjects, previously vaccinated with either two or three doses of GSK Biologicals’ HPV-16/18 vaccine according to a 0, 6-months schedule or a 0, 1, 6-months schedule in the study HPV-048 PRI (110659).
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Protection of trial subjects |
The study was cancelled before active (see attached statement). No patient entered the study, therefore no results / data are available.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Jul 2014
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Long term follow-up planned |
No
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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 |
Germany: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
99999
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Adults (18-64 years) |
0
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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 |
99999 is "Not applicable" value or 0 participants, the study was cancelled before active. No patient entered the study, therefore no results / data are available. | ||||||
Pre-assignment
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Screening details |
Study cancelled before active (see attached statement) | ||||||
Period 1
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Period 1 title |
Cancelled before active period (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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No-Arm | ||||||
Arm description |
- | ||||||
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 |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The product was not administered as the study was cancelled before active.
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Baseline characteristics reporting groups
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Reporting group title |
Cancelled before active period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
No-Arm
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Reporting group description |
- |
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End point title |
No endpoint results [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
The study was cancelled before active (see attached statement)
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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 study was cancelled before active (see attached statement). |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
The study was cancelled before active (see attached statement)
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
0
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Frequency threshold for reporting non-serious adverse events: 0% | |||
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: The study was cancelled before active (see attached statement). |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |