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    Clinical Trial Results:
    Safety and immunogenicity of 3 adjuvated reduced dose inactivated poliovirus vaccines (IPV-Al SSI) and non-adjuvated full dose IPV SSI, given as a booster vaccination to adolescents with a history of IPV vaccination at 3, 5, 12 months and 5 years of age

    Summary
    EudraCT number
    		 2014-000052-29
    Trial protocol
    		 DK  
    Global end of trial date
    05 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Nov 2016
    First version publication date
    10 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VIPV-04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02280447
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Statens Serum Institut
    Sponsor organisation address
    Artillerivej 5, Copenhagen, Denmark, 2300
    Public contact
    Toxicology and Clinical Development, Statens Serum Institut, +45 32683598, btc@ssi.dk
    Scientific contact
    Toxicology and Clinical Development, Statens Serum Institut, +45 32683598, btc@ssi.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    For each of the 3 poliovirus types 1, 2 and 3 to demonstrate the non-inferiority of the booster effect (day 28 / day 0 titres) of each of the 3 adjuvated reduced dose IPV-Al formulations (1/3 dose, 1/5 dose and 1/10 dose) compared to the non-adjuvated IPV (full dose)
    Protection of trial subjects
    Equipment and medication for treatment of an anaphylactic reaction were in place at all sites when administering the vaccines. After administration of the vaccine, the trial subject stayed at the trial site for 30 minutes under observation. Caution was taken in known cases of allergy to formaldehyde and aluminium. To minimise the occurrence of vasovagal syncope (i.e. fainting), the adolescents were offered to lie down during the administration of vaccine and blood drawings. To minimise the pain during administration of vaccine and blood drawings the adolescents were offered application of local anaesthetics, such as EMLA®, at the injection/sampling sites.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 240
    Worldwide total number of subjects
    240
    EEA total number of subjects
    240
    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)
    0
    Children (2-11 years)
    71
    Adolescents (12-17 years)
    169
    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
    		 The 10-15-years-old adolescents were recruited through advertisements in newspapers, social media, and posters at schools and institutions. All written texts in advertisements and posters etc. were approved in advance by the EC.

    Pre-assignment
    Screening details
    		 A total of 242 subjects were assessed for eligibility during the screening at Visit 1. Two subjects discontinued the trial before allocation to and receipt of the trial vaccine.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor
    Blinding implementation details
    This clinical trial was observer-blind. Only dedicated site staff and the CRA had access to vaccine dispensing, administration and accountability data where specific subject numbers were linked to the type of vaccine administered. These unblinded trial team members were not allowed to share information on the identity of the trial vaccines with other trial team members or any other person.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1/3 IPV-Al SSI
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    1/3 IPV-Al SSI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL was injected intramuscularly perpendicular to the skin in the deltoid muscle by use of a 23 Gauge, 25 mm (blue) Terumo hypodermic needle.

    Arm title
    		 1/5 IPV-Al SSI
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    1/5 IPV-Al SSI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL was injected intramuscularly perpendicular to the skin in the deltoid muscle by use of a 23 Gauge, 25 mm (blue) Terumo hypodermic needle.

    Arm title
    		 1/10 IPV-Al SSI
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    1/10 IPV-Al SSI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL was injected intramuscularly perpendicular to the skin in the deltoid muscle by use of a 23 Gauge, 25 mm (blue) Terumo hypodermic needle.

    Arm title
    		 IPV SSI
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    IPV SSI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL was injected intramuscularly perpendicular to the skin in the deltoid muscle by use of a 23 Gauge, 25 mm (blue) Terumo hypodermic needle.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: This trial was observer-blind. Only dedicated site staff and the CRA from Larix A/S had access to vaccine dispensing, administration and accountability data where specific subject numbers were linked to the type of vaccine administered. These unblinded trial team members were not allowed to share information on the identity of the trial vaccines with other trial team members or any other person.
    Number of subjects in period 1
    		1/3 IPV-Al SSI 1/5 IPV-Al SSI 1/10 IPV-Al SSI IPV SSI
    Started
    60
    61
    59
    60
    Completed
    60
    61
    59
    60

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 240 240
    Age categorical
    240 subjects enrolled. Mean (SD) age was 12.5 (1.6). Age groups were 10-12 (n=111) and 13-15 (n=129).
    Units: Subjects
        10-12 years of age
    		 111 111
        13-15 years of age
    		 129 129
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.5 ± 1.6 -
    Gender categorical
    Units: Subjects
        Female
    		 105 105
        Male
    		 135 135

    End points

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    End points reporting groups
    Reporting group title
    1/3 IPV-Al SSI
    Reporting group description
    		 -

    Reporting group title
    1/5 IPV-Al SSI
    Reporting group description
    		 -

    Reporting group title
    1/10 IPV-Al SSI
    Reporting group description
    		 -

    Reporting group title
    IPV SSI
    Reporting group description
    		 -

    Primary: Immunogenicity

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    End point title
    		 Immunogenicity [1] [2]
    End point description
    Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus type 1, 2 and 3 measured in pre-vaccination and post-vaccination serum samples by Vero Cell neutralising assay
    End point type
    Primary
    End point timeframe
    Visit 1 (day 0) to Visit 2 (day 28-35)
    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: Endpoint was booster effect defined as day 28/day 0 titres. On log2 scale, endpoint corresponded to difference since baseline in log2 titre analysed in an ANCOVA with treatment as factor and pre-vaccination log2 titre as covariate. 3 IPV-Al SSI formulations were compared to IPV SSI in the model including all treatment arms. Separate analyses were performed for each 3 poliovirus types. Estimated treatment differences were transformed back and presented as ratios of booster effects with 95% CI.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint is a ratio between 3 investigational arms versus a 4th comparator arm. This justifies that there is only ratios for the three investigational arms.
    End point values
    		 1/3 IPV-Al SSI 1/5 IPV-Al SSI 1/10 IPV-Al SSI
    Number of subjects analysed
    60
    61
    59
    Units: titre
    number (confidence interval 95%)
        Poliovirus Type 1
    0.402 (0.263 to 0.614)
    0.308 (0.202 to 0.469)
    0.169 (0.11 to 0.258)
        Poliovirus Type 2
    0.262 (0.174 to 0.394)
    0.275 (0.183 to 0.413)
    0.16 (0.106 to 0.241)
        Poliovirus Type 3
    0.232 (0.152 to 0.354)
    0.26 (0.17 to 0.395)
    0.143 (0.094 to 0.219)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Visit 1 (day 0) to visit 2 (day 28-35)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    1/3 IPV-Al SSI
    Reporting group description
    		 -

    Reporting group title
    1/5 IPV-Al SSI
    Reporting group description
    		 -

    Reporting group title
    1/10 IPV-Al SSI
    Reporting group description
    		 -

    Reporting group title
    IPV SSI
    Reporting group description
    		 -

    Serious adverse events
    		 1/3 IPV-Al SSI 1/5 IPV-Al SSI 1/10 IPV-Al SSI IPV SSI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 1/3 IPV-Al SSI 1/5 IPV-Al SSI 1/10 IPV-Al SSI IPV SSI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 60 (65.00%)
    30 / 61 (49.18%)
    36 / 59 (61.02%)
    37 / 60 (61.67%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complication
    Additional description: PT reported: Procedural pain and Ligament sprain
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    0
    0
    1
    Nervous system disorders
    Nervous system disorder
    Additional description: Reported PT: Headache and Presyncope
         subjects affected / exposed
    9 / 60 (15.00%)
    12 / 61 (19.67%)
    10 / 59 (16.95%)
    17 / 60 (28.33%)
         occurrences all number
    11
    12
    10
    18
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Injection site reaction and systemic adverse events
    Additional description: Reported PTs: Injection site reactions included pain, swelling, erythema, pruritus, haematoma, and warmth; systemic adverse events included influenza like illness, axillary pain, vessel puncture site pain, fatigue, and Pyrexia
         subjects affected / exposed
    31 / 60 (51.67%)
    21 / 61 (34.43%)
    28 / 59 (47.46%)
    25 / 60 (41.67%)
         occurrences all number
    46
    28
    41
    35
    Gastrointestinal disorders
    Gastrointestional disorders
    Additional description: Reported PTs: Nausea, Diarrhoea, Vomiting, Abdominal pain upper and Abdominal pain
         subjects affected / exposed
    9 / 60 (15.00%)
    5 / 61 (8.20%)
    10 / 59 (16.95%)
    9 / 60 (15.00%)
         occurrences all number
    11
    5
    14
    10
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: Reported PTs: Oropharyngeal pain, Cough and Pharyngeal inflammation
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 61 (1.64%)
    2 / 59 (3.39%)
    3 / 60 (5.00%)
         occurrences all number
    4
    1
    2
    3
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
    Additional description: Reported PTs: Rash, Erythema and Eczema
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 61 (1.64%)
    3 / 59 (5.08%)
    2 / 60 (3.33%)
         occurrences all number
    0
    1
    3
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorder
    Additional description: Reported PTs: Myalgia, Back pain, Muscle spasms
         subjects affected / exposed
    5 / 60 (8.33%)
    3 / 61 (4.92%)
    4 / 59 (6.78%)
    9 / 60 (15.00%)
         occurrences all number
    5
    3
    5
    9
    Infections and infestations
    Infection and infestations
    Additional description: Reported PTs: Gastroenteritis, Nasopharyngitis, Influenza, Vulvovaginal mycotic infection, Skin infection, Sinusitis, Pneumonia, Otitis externa, and Oral herpes
         subjects affected / exposed
    5 / 60 (8.33%)
    4 / 61 (6.56%)
    6 / 59 (10.17%)
    4 / 60 (6.67%)
         occurrences all number
    6
    5
    6
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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