Clinical Trial Results:
Characterization of cellular and humoral immunity in the elderly upon vaccination with the purified inactivated Japanese Encephalitis Vaccine IXIARO®
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Summary
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EudraCT number |
2010-020450-33 |
Trial protocol |
AT |
Global end of trial date |
12 Aug 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Jun 2022
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First version publication date |
17 Jun 2022
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Other versions |
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Summary report(s) |
Publication of study results |
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 |
IX-senesc2.0
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01398540 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria,
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Public contact |
Institute of Specific Prophylaxis and Tropical Medicine, Institute of Specific Prophylaxis and Tropical Medicine, 0043 140160-38290,
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Scientific contact |
Institute of Specific Prophylaxis and Tropical Medicine, Institute of Specific Prophylaxis and Tropical Medicine, 0043 140160-38290,
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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 |
29 Jun 2018
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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 |
12 Aug 2018
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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 |
Antibody titres 10 weeks after the first vaccination (=6 weeks after the 2. vaccination)
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Protection of trial subjects |
Communication always aimed to keep the subjects informed on the upcoming steps (such as blood draw or vaccination) and thereby reduce stress. Furthermore guidelines to reduce pain at vaccination were followed (adequate communication, distraction and instruction for breathing teqniques offered if required).
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Background therapy |
- | ||
Evidence for comparator |
not applicable | ||
Actual start date of recruitment |
15 Nov 2010
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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 |
Austria: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
60
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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) |
36
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From 65 to 84 years |
24
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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 |
Eligibility was checked according to inclusion and exclusion criteria (Vaccination cards were reviewed for prior vaccinations, medical diagnoses and medication and were requested) | |||||||||
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Period 1
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Period 1 title |
baseline (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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young | |||||||||
Arm description |
Participants aged between 18 and 40 years | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
IXIARO (R)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
in total 2 vaccination doses (0.5ml) per subject (4 weeks apart +/- 3 days) applied intramuscularly (M. deltoideus)
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Arm title
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elderly | |||||||||
Arm description |
aged above 60 years | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
IXIARO (R)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
in total 2 vaccination doses (0.5ml) per subject (4 weeks apart +/- 3 days) applied intramuscularly (M. deltoideus)
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Baseline characteristics reporting groups
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Reporting group title |
baseline
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
young
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Reporting group description |
Participants aged between 18 and 40 years | ||
Reporting group title |
elderly
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Reporting group description |
aged above 60 years | ||
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End point title |
JEV-PRNT50 6 weeks after the 2nd dose | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 weeks after the 2nd vaccine dose
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Statistical analysis title |
Differences in antibody titers at 6 weeks | ||||||||||||
Statistical analysis description |
Based on
prior investigations the standard deviation of loge titres was assumed to be 0.5. With respect to previous study
results, a difference of 1:3 in titres of the elderly compared to the young study participants was deemed relevant.
Based on these data the standardized effect size is 1. Due to the multiple endpoints sample size calculation was
performed on the basis of a corrected alpha error of 0.01.
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Comparison groups |
young v elderly
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
General linear model | ||||||||||||
Confidence interval |
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| Notes [1] - A difference of 1:3 in titres of the elderly compared to the young study participants was deemed relevant |
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Adverse events information [1]
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Timeframe for reporting adverse events |
until last patient visit
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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 |
1
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Reporting groups
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Reporting group title |
young
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Reporting group description |
Participants aged between 18 and 40 years | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
elderly
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Reporting group description |
aged above 60 years | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 events were non-systemically recorded and included expected local and systemic reactions after vaccination (as listed in the product information) such as transient pain, swelling, redness at injection site or headache. |
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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? Yes | |||
Date |
Amendment |
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23 Apr 2012 |
elderly study group inclusion criteria was chanded from: 65 year and above to 60 years and above |
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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 | |||
