Clinical Trial Results:
An observational follow up study of a randomised parallel group phase IV study to evaluate the duration of the immune response to vaccine and non-vaccine HPV types in UK adolescent females who received either Cervarix or Gardasil Human Papillomavirus (HPV) vaccines.
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Summary
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EudraCT number |
2016-002083-13 |
Trial protocol |
GB |
Global end of trial date |
31 Aug 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jan 2019
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First version publication date |
02 Jan 2019
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Other versions |
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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 |
HPV followup
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02811068 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Public Health England
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Sponsor organisation address |
Manor Farm Road, Porton Down, Salisbury, United Kingdom, SP1 3QH
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Public contact |
Elizabeth Coates, Public Health England, 44 01980612922, elizabeth.coates@phe.gov.uk
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Scientific contact |
Elizabeth Coates, Public Health England, 44 01980612922, elizabeth.coates@phe.gov.uk
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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 |
31 Aug 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Aug 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Aug 2017
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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 |
Technical version:
The measurement of antibody titres elicited to HPV vaccine and non-vaccine types following vaccination with either Cervarix or Gardasil 5-7 years post first immunisation and comparison between vaccines as well as over time.
Lay version:
To measure how much antibody is still present is in the blood of those vaccinated in our original study 5-7 years after they were vaccinated with either Cervarix or Gardisil HPV vaccines, including comparing the two groups with each other.
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Protection of trial subjects |
Subjects will not be monitored in terms of safety outcomes as the study consists of a single visit requiring a blood draw. no investigational medicinal products will be given so it will not be necessary to collect safety data or to report adverse events.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2016
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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 |
United Kingdom: 58
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Worldwide total number of subjects |
58
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EEA total number of subjects |
58
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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) |
58
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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 |
Subjects were recruited from a cohort of participants in a previous study, where participants had been randomised 1:1 to receive either the Cervarix or Gardasil vaccine in a three dose schedule, and provided blood samples at 1,2,7 and 12 months following the first dose to evaluate immunogenicity to vaccine and non-vaccine HPV genotypes. | |||||||||
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Pre-assignment
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Screening details |
absence of any bleeding disorders | |||||||||
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Period 1
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Period 1 title |
Entire trial 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 | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Subjects who received Cervarix in a previous clinical trial. | |||||||||
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 |
0.5ml
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Investigational medicinal product name |
GARDASIL
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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 |
0.5ml
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Arm title
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Subjects who received Gardasil in a previous clinical trial | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Gardasil
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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 |
0.5
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Baseline characteristics reporting groups
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Reporting group title |
Entire trial period.
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Subjects who received Cervarix in a previous clinical trial.
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Reporting group description |
- | ||
Reporting group title |
Subjects who received Gardasil in a previous clinical trial
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Reporting group description |
- | ||
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End point title |
Proportion with detectable titres at followup | |||||||||
End point description |
Proportion positive for type 16
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End point type |
Primary
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End point timeframe |
7 yrs after vaccination
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Statistical analysis title |
Pre Planned Analysis | |||||||||
Statistical analysis description |
Groups will be compared by T-test on logged data or Kruskal-Wallis test as appropriate
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Comparison groups |
Subjects who received Cervarix in a previous clinical trial. v Subjects who received Gardasil in a previous clinical trial
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
< 5 | |||||||||
Method |
t-test, 2-sided | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Subjects were not monitored in terms of safety outcomes as the study consists of a single visit and one blood draw. No investigational medicinal products were given so it was not necessary to collect safety data or to report adverse events.
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Assessment type |
Non-systematic | ||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
Study Cohort
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Reporting group description |
- | ||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||
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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? No | |||
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 | |||
