Clinical Trial Results:
Long term immunity and safety following vaccination with the Japanese Encephalitis vaccine IC51 (IXIARO®, JESPECT®) in a pediatric population in non-endemic countries. Uncontrolled, Phase 3 Follow-up study.
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Summary
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EudraCT number |
2010-022266-27 |
Trial protocol |
DE |
Global end of trial date |
15 Sep 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Feb 2016
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First version publication date |
03 Jul 2015
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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 |
IC51-324
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01246479 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Valneva Austria GmbH
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Sponsor organisation address |
Campus Vienna Biocenter 3, Vienna, Austria, 1030
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Public contact |
Clinical Operations, Valneva Austria GmbH, 0043 1206200, info@valneva.com
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Scientific contact |
Clinical Operations, Valneva Austria GmbH, 0043 1206200, info@valneva.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000559-PIP01-09 | ||
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 |
09 Feb 2015
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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 |
15 Sep 2014
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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 assess long-term immunity following vaccination with purified inactivated Japanese Encephalitis (JE) vaccine IC51 in terms of Geometric Mean Titers (GMTs) and rate of subjects with a PRNT50 ≥ 1:10 in a pediatric population from regions where JE is not endemic.
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Protection of trial subjects |
To avoid unreasonable visits and blood samplings, subjects were to be withdrawn from the study as soon as the result of the PRNT analysis of Visit 1, 2 or 3 was known to be negative (PRNT50 titer < 1:10).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Oct 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 |
Germany: 7
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Country: Number of subjects enrolled |
Australia: 6
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Country: Number of subjects enrolled |
United States: 10
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Worldwide total number of subjects |
23
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EEA total number of subjects |
7
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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) |
4
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Adolescents (12-17 years) |
19
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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 |
Subjects were recruited in 6 study centers located in Australia, Germany and the United States. Recruitment started on 20-Oct-2010 and was completed on 20-Aug-2012. Study visits occurred 7, 12, 24 and 36 months after the first IC51 vaccination in parent study IC51-322. | ||||||||||||
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Pre-assignment
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Screening details |
Uncontrolled, open-label Phase 3 follow-up study in subjects who received 2 injections of IC51 and participated in the immunogenicity subgroup of the parent study IC51-322. | ||||||||||||
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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 |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Safety and Immunogenicity follow-up M7 - M36 | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
IC51
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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 |
IC51 was only administered in parent study IC51-322 where subjects received 2 vaccinations of either 0.25 ml or 0.5 ml IC51 (depending on their age) at an interval of 4 weeks. IC51-324 is a follow-up study to examine long-term immunity.
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Baseline characteristics reporting groups
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Reporting group title |
Overall study
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Reporting group description |
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End points reporting groups
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Reporting group title |
Safety and Immunogenicity follow-up M7 - M36
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Reporting group description |
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End point title |
Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322). [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 Months after the first IC51 vaccination.
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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: 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 |
GMT for JEV neutralizing antibodies measured using the PRNT at Month 12 after the first IC51 vaccination (in study IC51-322). | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
12 Months after the first IC51 vaccination.
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
AEs were recorded at Visits 1-4. Any AE reported as “not recovered/not resolved” at Visit 4 in study IC51-322 and all new abnormalities occurring after Visit 4 in IC51-322 were documented as AEs in study IC51-324.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Safety Population
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Reporting group description |
All subjects who were enrolled in the study. | ||||||||||||||||||||||||||||||||||||
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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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31 Jan 2012 |
Due to change of primary objective in parent study IC51-322 from immunogenicity to safety (Clinical Study Protocol V10.0), limitation of follow-up on long-term immunogenicity in IC51-324 to those subjects that participated in the immunogenicity subgroup in IC51-322. Revision of incl./excl. criteria, estimated sample size and planned analyses. Updates on background information, number of participating study centers and immunogenicity assay. |
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11 Jun 2013 |
Name change of Sponsor. Interim Analysis after Month 12 was removed (only Interim Analysis after M24 was performed). |
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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. | |||
| As the number of subjects in individual age groups was low a meaningful comparison between age/dose groups is not possible. | |||
