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    Clinical Trial Results:
    SAFETY AND IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (IXIARO®) IN A PEDIATRIC POPULATION. OPEN-LABEL, RANDOMIZED, ACTIVE CONTROLLED, PHASE 3 STUDY.

    Summary
    EudraCT number
    		 2009-015588-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Jul 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Apr 2016
    First version publication date
    15 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IC51-323
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01041573
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Valneva Austria GmbH (formerly Intercell AG)
    Sponsor organisation address
    Campus Vienna Biocenter 3, Vienna, Austria, 1030
    Public contact
    Clinical Operations, Valneva Austria GmbH (formerly Intercell AG), 0043 1206200, info@valneva.com
    Scientific contact
    Clinical Operations, Valneva Austria GmbH (formerly Intercell AG), 0043 1206200, info@valneva.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000559-PIP01-09
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Nov 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assessment of the systemic and local safety profile of IC51 vaccine in a pediatric population from regions where Japanese Encephalitis is endemic. Assessment of the immunogenicity of IC51 using Geometric Mean Titers (GMTs) and Seroconversion Rates (SCRs) at Day 56. Establishment of the appropriate IC51 dose (0.25 ml or 0.5 ml) for subjects aged ≥ 3 to < 12 years.
    Protection of trial subjects
    An independent Data Safety Monitoring Board (DSMB) analyzed safety of vaccination with the 0.25 ml and 0.5 ml dose after the dose finding run‐in phase in children aged ≥ 3 to < 12 years. The subject’s legal representative or the subject, as applicable, was asked to report all symptoms (solicited and unsolicited AEs) after vaccination with IC51.
    Background therapy
    		 -
    Evidence for comparator
    		 Control vaccines were Prevnar® for children below 12 months of age and inactivated HAVRIX®720 for children aged 12 months and above at randomization. The control group allowed for comparison of adverse event rates with background incidences. Subjects aged ≥ 2 months to < 1 year were randomized in a 2:1 ratio to receive IC51 (0.25 ml) or Prevnar®. Children aged ≥ 1 to < 3 years and ≥ 12 to < 18 years were randomized in a 3:1 ratio to receive IC51 (0.25 ml < 3 years or 0.5 ml ≥ 12 years) or HAVRIX®720. For subjects aged ≥ 3 to < 12 years, a dose finding run‐in phase was performed, in which subjects were randomized 1:1 to receive either the 0.25 ml or the 0.5 ml dose of IC51. The appropriate dose was then determined based on an interim analysis. Subjects randomized into one of the control groups were offered vaccination with the other safety comparator vaccine (i.e. either HAVRIX®720 or Prevnar® or another licensed Pneumococcal Conjugate Vaccine) after concluding the study. Additionally, subjects were offered other vaccination (e.g. Varicella vaccine, Meningococcal vaccine, MMR vaccine) after concluding the study. The selection of which was based on the medical need of the subject. Subjects randomized into the IC51 group were offered vaccination with both HAVRIX®720 and Prevnar®/another licensed Pneumococcal Conjugate Vaccine after concluding the study.
    Actual start date of recruitment
    17 Mar 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 7 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Philippines: 1869
    Worldwide total number of subjects
    1869
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    620
    Children (2-11 years)
    929
    Adolescents (12-17 years)
    320
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited at 3 study centers in the Philippines. Recruitment started on 17-Mar-2010 and was completed on 10-Dec-2010.

    Pre-assignment
    Screening details
    		 Open-label, randomized, active-controlled Phase 3 study in children aged ≥ 2 months to < 18 years.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IC51 0.25 ml group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IC51
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged ≥ 2 months to < 3 years received 2 vaccinations of 0.25 ml IC51 at an intervals of 4 weeks (Day 0 and 28).

    Arm title
    		 IC51 0.5 ml group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IC51
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged ≥ 12 to < 18 years received 2 vaccinations of 0.5 ml IC51 at an intervals of 4 weeks (Day 0 and 28).

    Arm title
    		 Prevnar® group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prevnar®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged ≥ 2 to < 6 months received 4 vaccinations on Days 0, 28, 56 and Month 7‐13 (subjects aged ≥ 2 to < 6 months were to receive the 4th vaccination when 12‐15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination). Subjects aged ≥ 6 months to < 1 year received 3 vaccinations on Days 0, 56 and Month 7.

    Arm title
    		 Havrix®720 group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Havrix®720
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects aged ≥ 1 to < 18 years received 2 vaccinations on Day 0 and Month 7.

    Number of subjects in period 1
    		IC51 0.25 ml group IC51 0.5 ml group Prevnar® group Havrix®720 group
    Started
    871
    540
    64
    394
    Completed
    858
    535
    62
    387
    Not completed
    13
    5
    2
    7
         Relocation
    4
    1
    1
    3
         Adverse event, serious fatal
    -
    1
    -
    -
         Consent withdrawn by subject
    5
    2
    -
    2
         Positive for anti-HCV
    -
    1
    -
    -
         Adverse event, non-fatal
    2
    -
    -
    -
         Further blood extraction
    1
    -
    -
    -
         Lost to follow-up
    1
    -
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IC51 0.25 ml group
    Reporting group description
    		 -

    Reporting group title
    IC51 0.5 ml group
    Reporting group description
    		 -

    Reporting group title
    Prevnar® group
    Reporting group description
    		 -

    Reporting group title
    Havrix®720 group
    Reporting group description
    		 -

    Reporting group values
    		 IC51 0.25 ml group IC51 0.5 ml group Prevnar® group Havrix®720 group Total
    Number of subjects
    		 871 540 64 394 1869
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 2.41 (0.2 to 11.9) 10.64 (3.1 to 17.8) 0.67 (0.2 to 1) 5.98 (1 to 17.9) -
    Gender categorical
    Units: Subjects
        Female
    		 449 249 30 197 925
        Male
    		 422 291 34 197 944

    End points

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    End points reporting groups
    Reporting group title
    IC51 0.25 ml group
    Reporting group description
    		 -

    Reporting group title
    IC51 0.5 ml group
    Reporting group description
    		 -

    Reporting group title
    Prevnar® group
    Reporting group description
    		 -

    Reporting group title
    Havrix®720 group
    Reporting group description
    		 -

    Subject analysis set title
    Ixiaro®, subjects aged ≥ 2 months to < 1 year
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects aged ≥ 2 months to < 1 year at Visit 1 who received IC51 0.25 ml

    Subject analysis set title
    Prevnar®, subjects aged ≥ 2 months to < 1 year
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects aged ≥ 2 months to < 1 year at Visit 1 who received control, i.e. Prevnar®

    Subject analysis set title
    Ixiaro®, subjects aged ≥ 1 year
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects aged ≥ 1 year at Visit 1 who received any Ixiaro® dose, i.e. IC51 0.25 ml or IC51 0.5 ml

    Subject analysis set title
    Havrix®720, subjects aged ≥ 1 year
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects aged ≥ 1 year at Visit 1 who received control, i.e. Havrix®720

    Primary: Rate of subjects with SAEs and medically attended AEs up to Day 56 after the first vaccination.

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    End point title
    		 Rate of subjects with SAEs and medically attended AEs up to Day 56 after the first vaccination.
    End point description
    End point type
    Primary
    End point timeframe
    56 Days after the first IC51 vaccination.
    End point values
    		 Ixiaro®, subjects aged ≥ 2 months to < 1 year Prevnar®, subjects aged ≥ 2 months to < 1 year Ixiaro®, subjects aged ≥ 1 year Havrix®720, subjects aged ≥ 1 year
    Number of subjects analysed
    131
    64
    1280
    394
    Units: % of subjects
        number (confidence interval 95%)
    38.2 (29.8 to 47.1)
    42.2 (29.9 to 55.2)
    16.1 (14.1 to 18.2)
    14.2 (10.9 to 18.1)
    Statistical analysis title
    		 D56 comparison in subjects < 1 year
    Statistical analysis description
    Comparison of the number of subjects with the event across the treatment groups.
    Comparison groups
    Ixiaro®, subjects aged ≥ 2 months to < 1 year v Prevnar®, subjects aged ≥ 2 months to < 1 year
    Number of subjects included in analysis
    195
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.641
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 D56 comparison in subjects > 1 year
    Statistical analysis description
    Comparison of the number of subjects with the event across the treatment groups
    Comparison groups
    Havrix®720, subjects aged ≥ 1 year v Ixiaro®, subjects aged ≥ 1 year
    Number of subjects included in analysis
    1674
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were recorded at all study visits until Month 7.
    Adverse event reporting additional description
    Certain events were captured systemically (use of diary); events such as injection site pain might not have been assessable in the very young study participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    IC51 0.5 ml
    Reporting group description
    		 -

    Reporting group title
    IC51 0.25 ml
    Reporting group description
    		 -

    Reporting group title
    Havrix®720
    Reporting group description
    		 -

    Reporting group title
    Prevnar®
    Reporting group description
    		 -

    Serious adverse events
    		 IC51 0.5 ml IC51 0.25 ml Havrix®720 Prevnar®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 540 (1.30%)
    16 / 871 (1.84%)
    10 / 394 (2.54%)
    1 / 64 (1.56%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    0 / 871 (0.00%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    1 / 871 (0.11%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kawasaki's disease
         subjects affected / exposed
    1 / 540 (0.19%)
    0 / 871 (0.00%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Familial periodic paralysis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    0 / 871 (0.00%)
    1 / 394 (0.25%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    5 / 871 (0.57%)
    3 / 394 (0.76%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Stillbirth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    0 / 871 (0.00%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    0 / 871 (0.00%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Strabismus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    0 / 871 (0.00%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    0 / 871 (0.00%)
    1 / 394 (0.25%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    3 / 871 (0.34%)
    2 / 394 (0.51%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    2 / 871 (0.23%)
    1 / 394 (0.25%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    1 / 871 (0.11%)
    1 / 394 (0.25%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    2 / 871 (0.23%)
    1 / 394 (0.25%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    1 / 871 (0.11%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    1 / 871 (0.11%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    0 / 871 (0.00%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    0 / 871 (0.00%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Typhoid fever
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    0 / 871 (0.00%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 540 (0.19%)
    0 / 871 (0.00%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    1 / 871 (0.11%)
    0 / 394 (0.00%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 540 (0.00%)
    0 / 871 (0.00%)
    1 / 394 (0.25%)
    0 / 64 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IC51 0.5 ml IC51 0.25 ml Havrix®720 Prevnar®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    300 / 540 (55.56%)
    691 / 871 (79.33%)
    252 / 394 (63.96%)
    57 / 64 (89.06%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    31 / 540 (5.74%)
    10 / 871 (1.15%)
    10 / 394 (2.54%)
    0 / 64 (0.00%)
         occurrences all number
    37
    10
    10
    0
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    35 / 540 (6.48%)
    122 / 871 (14.01%)
    36 / 394 (9.14%)
    8 / 64 (12.50%)
         occurrences all number
    36
    127
    40
    10
    Injection site pain
         subjects affected / exposed
    65 / 540 (12.04%)
    15 / 871 (1.72%)
    20 / 394 (5.08%)
    0 / 64 (0.00%)
         occurrences all number
    74
    17
    20
    0
    Tenderness
    Additional description: = pain upon touching at vaccination site
         subjects affected / exposed
    48 / 540 (8.89%)
    38 / 871 (4.36%)
    27 / 394 (6.85%)
    8 / 64 (12.50%)
         occurrences all number
    55
    40
    27
    10
    Hardening
    Additional description: Hardening at vaccination site
         subjects affected / exposed
    8 / 540 (1.48%)
    10 / 871 (1.15%)
    2 / 394 (0.51%)
    5 / 64 (7.81%)
         occurrences all number
    8
    10
    2
    6
    Swelling
    Additional description: Swelling at vaccination site
         subjects affected / exposed
    14 / 540 (2.59%)
    34 / 871 (3.90%)
    12 / 394 (3.05%)
    5 / 64 (7.81%)
         occurrences all number
    15
    35
    15
    6
    Redness
    Additional description: at injection site
         subjects affected / exposed
    22 / 540 (4.07%)
    81 / 871 (9.30%)
    25 / 394 (6.35%)
    23 / 64 (35.94%)
         occurrences all number
    22
    93
    25
    30
    Flu-like symptoms
         subjects affected / exposed
    16 / 540 (2.96%)
    21 / 871 (2.41%)
    16 / 394 (4.06%)
    0 / 64 (0.00%)
         occurrences all number
    17
    23
    16
    0
    Fever
         subjects affected / exposed
    61 / 540 (11.30%)
    244 / 871 (28.01%)
    49 / 394 (12.44%)
    24 / 64 (37.50%)
         occurrences all number
    76
    316
    53
    31
    Irritability
         subjects affected / exposed
    6 / 540 (1.11%)
    87 / 871 (9.99%)
    16 / 394 (4.06%)
    9 / 64 (14.06%)
         occurrences all number
    9
    111
    17
    16
    Excessive fatigue
         subjects affected / exposed
    12 / 540 (2.22%)
    28 / 871 (3.21%)
    5 / 394 (1.27%)
    5 / 64 (7.81%)
         occurrences all number
    14
    32
    5
    7
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 540 (0.56%)
    30 / 871 (3.44%)
    10 / 394 (2.54%)
    5 / 64 (7.81%)
         occurrences all number
    3
    32
    10
    5
    Vomiting
         subjects affected / exposed
    10 / 540 (1.85%)
    58 / 871 (6.66%)
    13 / 394 (3.30%)
    5 / 64 (7.81%)
         occurrences all number
    11
    69
    14
    5
    Diarrhea
         subjects affected / exposed
    6 / 540 (1.11%)
    94 / 871 (10.79%)
    13 / 394 (3.30%)
    6 / 64 (9.38%)
         occurrences all number
    6
    113
    13
    7
    Skin and subcutaneous tissue disorders
    Heat rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 540 (0.74%)
    9 / 871 (1.03%)
    4 / 394 (1.02%)
    4 / 64 (6.25%)
         occurrences all number
    4
    10
    4
    5
    Rash
         subjects affected / exposed
    5 / 540 (0.93%)
    49 / 871 (5.63%)
    6 / 394 (1.52%)
    9 / 64 (14.06%)
         occurrences all number
    5
    57
    6
    9
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    67 / 540 (12.41%)
    326 / 871 (37.43%)
    97 / 394 (24.62%)
    33 / 64 (51.56%)
         occurrences all number
    72
    414
    115
    50
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 540 (0.56%)
    58 / 871 (6.66%)
    14 / 394 (3.55%)
    9 / 64 (14.06%)
         occurrences all number
    3
    61
    14
    12
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 540 (2.59%)
    77 / 871 (8.84%)
    27 / 394 (6.85%)
    5 / 64 (7.81%)
         occurrences all number
    16
    89
    27
    6
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 540 (1.48%)
    45 / 871 (5.17%)
    17 / 394 (4.31%)
    3 / 64 (4.69%)
         occurrences all number
    8
    48
    19
    5
    Metabolism and nutrition disorders
    Loss of appetite
         subjects affected / exposed
    11 / 540 (2.04%)
    65 / 871 (7.46%)
    13 / 394 (3.30%)
    6 / 64 (9.38%)
         occurrences all number
    14
    78
    16
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Feb 2010
    - Lower age limit for the youngest age group lowered from 6 to 2 months. Visit schedule for subjects aged ≥ 2 to < 6 months receiving Prevnar® adapted to allow vaccination at Day 28. - For IC51 treatment arm subject numbers were amended: 130 subjects aged ≥ 2 months to < 1 year incl. 30 subjects for immunogenicity subgroup; 639 subjects aged ≥ 1 to < 3 years; 240 subjects aged ≥ 12 to < 18 years; total number of subjects treated with IC51 = 1409 subjects incl. 495 subjects from immunogenicity subgroup. Total sample size = 1867. - Details on introduction of enrolment cap for subjects recruited into the ≥ 6 to < 12 months age group to warrant enrolment of at least 45 subjects aged ≥ 2 to < 6 months following approval of the amendment. - Vaccination history of Prevnar® (Excl. Crit. #3) is an excl. crit. applicable for subjects < 1 year only. - Excl. Crit. #4 amended: children < 6 months of age are excluded from the study if they receive active or passive immunizations within one week before and one week after each IC51 vaccination. - Safety laboratory testing restricted to subjects aged ≥ 6 months. - Study hypothesis described in more detail. - Evaluation of risk‐benefit ratio broadened by additional identified benefits. - Relevant protocol deviations which might be noticed after 1st vaccination leading to either subject withdrawal from further vaccination/study participation specified in more detail. - Clarifications on definition of solicited/unsolicited AEs, capturing of solicited/unsolicited AEs in the eCRF and on the causality assessment of solicited AEs added. - Details on statistical methods applied during Interim Analysis added. - Reporting of concomitant symptoms during a SAE clarified. - Approval status of IXIARO®/JESPECT® added. - Implementation dates for protocol version 1.0 and 2.0 amended/added. - Contact details updated. - Details on Data Safety Monitoring Board added. - Error re frequency of AEs following JE-VAX vaccination corrected.

    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
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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