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    Clinical Trial Results:
    Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)

    Summary
    EudraCT number
    		 2016-001964-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Oct 2017
    First version publication date
    20 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HAF85
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01838070
    WHO universal trial number (UTN)
    		 U1111-1127-7211
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Korea Ltd
    Sponsor organisation address
    11 fl, 235, Banpo-daero, Seocho-gu Seoul, Korea, Republic of, 137-804
    Public contact
    Global Medical Affairs Rep., Sanofi Pasteur Korea Ltd, 82 22136 9533, RegistryContactUS@sanofipasteur.com
    Scientific contact
    Global Medical Affairs Rep., Sanofi Pasteur Korea Ltd, 82 22136 9533, RegistryContactUS@sanofipasteur.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the routine practice, according to Korea Food and Drug Administration "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
    Protection of trial subjects
    No vaccination was administered during this trial. Subjects in this trial previously received AVAXIM 160U (Hepatitis A vaccine) and safety events occurring within 30 days after vaccination under the routine practice during the 4-year surveillance period is reported here.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    04 Nov 2011
    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
    Korea, Republic of: 614
    Worldwide total number of subjects
    614
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    14
    Adults (18-64 years)
    596
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled for a 4-year surveillance period (04 November 2011 to 03 November 2015) at 16 clinic centers in South Korea.

    Pre-assignment
    Screening details
    		 A total of 614 subjects whose case report forms were retrieved were included in the safety evaluation.

    Period 1
    Period 1 title
    4-year surveillance period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 All subjects
    Arm description
    		 Subjects who were 16 to 84 years old who previously received Avaxim 160U for 16 years old and older (Hepatitis A vaccine) injection once, were enrolled during the 4-year surveillance period, and whose Case Report forms were retrieved.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avaxim® 160U Injection (Hepatitis A Vaccine)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single injection on Day 0.

    Number of subjects in period 1
    		All subjects
    Started
    614
    Completed
    614

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 Subjects who were 16 to 84 years old who previously received Avaxim 160U for 16 years old and older (Hepatitis A vaccine) injection once, were enrolled during the 4-year surveillance period, and whose Case Report forms were retrieved.

    Reporting group values
    		 All subjects Total
    Number of subjects
    		 614 614
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 14 14
        Adults (18-64 years)
    		 596 596
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.19 ± 8.25 -
    Gender categorical
    Units: Subjects
        Female
    		 386 386
        Male
    		 228 228

    End points

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    End points reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 Subjects who were 16 to 84 years old who previously received Avaxim 160U for 16 years old and older (Hepatitis A vaccine) injection once, were enrolled during the 4-year surveillance period, and whose Case Report forms were retrieved.

    Primary: Number of Subjects Reporting Solicited Injection-Site and Systemic Events Following A Single Dose of Avaxim 160U Injection (Hepatitis A Vaccine)

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    End point title
    		 Number of Subjects Reporting Solicited Injection-Site and Systemic Events Following A Single Dose of Avaxim 160U Injection (Hepatitis A Vaccine) [1]
    End point description
    1. Solicited injection site reaction (Pain and Erythema) occurring during 7 days after the AVAXIM 160U administration during the 4-year surveillance period. Grade 3: Pain, Significant, prevents daily activity and Erythema, >100 mm. 2. Solicited systemic adverse reactions (Fever [Temperature], Headache, Myalgia or Arthralgia, Asthenia and Gastro-intestinal disorders) occurring during 7 days after the AVAXIM 160U administration during the 4-year surveillance period. Grade 3: Fever, ≥39.0°C; Headache, Myalgia, Arthralgia, Asthenia, and Gastro-intestinal disorders, Significant, prevents daily activity.
    End point type
    Primary
    End point timeframe
    7 days after the AVAXIM 160U administration during the 4-year surveillance period.
    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: Descriptive analyses were performed based on the study group and the study vaccine previously administered for this outcome.
    End point values
    		 All subjects
    Number of subjects analysed
    614
    Units: Number of subjects
    number (not applicable)
        Any Injection site Pain
    9
        Grade 3 Injection site Pain
    0
        Any Injection site Erythema
    3
        Grade 3 Injection site Erythema
    0
        Any Fever
    3
        Grade 3 Fever
    0
        Any Headache
    4
        Grade 3 Headache
    0
        Any Myalgia
    2
        Grade 3 Myalgia
    0
        Any Arthralgia
    0
        Grade 3 Arthralgia
    0
        Any Asthenia
    0
        Grade 3 Asthenia
    0
        Any Gastro-intestinal disorders
    1
        Grade 3 Gastro-intestinal disorders
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects Reporting Unexpected Adverse Events Following A Single Dose of Avaxim 160U Injection (Hepatitis A Vaccine)

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    End point title
    		 Number of Subjects Reporting Unexpected Adverse Events Following A Single Dose of Avaxim 160U Injection (Hepatitis A Vaccine)
    End point description
    The number subjects with unsolicited adverse events following a single dose of Avaxim 160 U Injection (Hepatitis A Vaccine) are reported.
    End point type
    Other pre-specified
    End point timeframe
    30 days after the AVAXIM 160U administration during the 4-year surveillance period.
    End point values
    		 All subjects
    Number of subjects analysed
    614
    Units: Number of subjects
    number (not applicable)
        Bronchitis
    4
        Pharyngitis
    4
        Nasopharyngitis
    3
        Influenza
    1
        Laryngitis
    1
        Vaginal infection
    1
        Vulvovaginal candidiasis
    1
        Stomatitis
    1
        Vomiting
    1
        Chest pain
    1
        Inflammation
    1
        Cough
    2
        Conjunctival disorder
    1
        Back pain
    1
        Dizziness
    1
        Ectropion of cervix
    1
        Uterine cervical erosion
    1
        Vulvovaginal pruritus
    1
        Dermatitis contact
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected throughout the 4-year surveillance period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 Subjects who were 16 to 84 years old who previously received Avaxim 160U for 16 years old and older (Hepatitis A vaccine) injection once, were enrolled during the 4-year surveillance period, and whose Case Report forms were retrieved.

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 614 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 614 (2.28%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Inflammation
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Eye disorders
    Conjunctival disorder
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    2 / 614 (0.33%)
         occurrences all number
    2
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Ectropion of cervix
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Uterine cervical erosion
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 614 (0.33%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 614 (0.65%)
         occurrences all number
    4
    Pharyngitis
         subjects affected / exposed
    4 / 614 (0.65%)
         occurrences all number
    4
    Nasopharyngitis
         subjects affected / exposed
    3 / 614 (0.49%)
         occurrences all number
    3
    Influenza
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Laryngitis
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Vaginal infection
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 614 (0.16%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Aug 2013
    Updated inclusion criteria, methods of recruitment, and informed consent forms.

    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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