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    Clinical Trial Results:
    Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A vaccine) Administered 6 Months Apart in Healthy Toddlers, Children and Adolescents Aged 12 Months to 15 Years in China

    Summary
    EudraCT number
    2015-003190-14
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    10 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Jun 2016
    First version publication date
    17 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HAF87
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02011763
    WHO universal trial number (UTN)
    U1111-1127-7652
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Responsible Medical Officer, Sanofi Pasteur SA, 33 04 37 37 7384, eric.desauziers@sanofipasteur.com
    Scientific contact
    Responsible Medical Officer, Sanofi Pasteur SA, 33 04 37 37 7384, eric.desauziers@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
    21 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety of Avaxim 80U Pediatric vaccine after each dose of vaccine administered 6 months apart, in subjects aged 12 months to 15 years.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were enrolled and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    06 Dec 2013
    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
    China: 355
    Worldwide total number of subjects
    355
    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)
    270
    Children (2-11 years)
    51
    Adolescents (12-17 years)
    34
    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
    Study subjects were enrolled from 06 December 2013 to 11 February 2014 at 1 clinic center in China.

    Pre-assignment
    Screening details
    A total of 355 subjects who met all inclusion and none of the exclusion criteria were enrolled and vaccinated in this trial.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Avaxim® 80U Pediatric Group 1
    Arm description
    Infants and toddlers (≤ 23 months) received 2 injections of Avaxim® 80U Pediatric vaccine 6 months apart.
    Arm type
    Experimental

    Investigational medicinal product name
    Avaxim® 80U Pediatric
    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, 1 injection each on Day 0 and Day 180.

    Arm title
    Avaxim® 80U Pediatric Group 2
    Arm description
    Children (aged 2 to 11 years) and adolescents (aged 12 to 15 years) received 2 injections of Avaxim® 80U Pediatric vaccine.
    Arm type
    Experimental

    Investigational medicinal product name
    Avaxim® 80U Pediatric
    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, 1 injection each on Day 0 and Day 180.

    Number of subjects in period 1
    Avaxim® 80U Pediatric Group 1 Avaxim® 80U Pediatric Group 2
    Started
    270
    85
    Completed
    257
    75
    Not completed
    13
    10
         Consent withdrawn by subject
             12
             6
         Lost to follow-up
             1
             4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Avaxim® 80U Pediatric Group 1
    Reporting group description
    Infants and toddlers (≤ 23 months) received 2 injections of Avaxim® 80U Pediatric vaccine 6 months apart.

    Reporting group title
    Avaxim® 80U Pediatric Group 2
    Reporting group description
    Children (aged 2 to 11 years) and adolescents (aged 12 to 15 years) received 2 injections of Avaxim® 80U Pediatric vaccine.

    Reporting group values
    Avaxim® 80U Pediatric Group 1 Avaxim® 80U Pediatric Group 2 Total
    Number of subjects
    270 85 355
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    270 0 270
        Children (2-11 years)
    0 51 51
        Adolescents (12-17 years)
    0 34 34
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    1.6 ± 0.1 9.8 ± 3.4 -
    Gender categorical
    Units: Subjects
        Female
    137 35 172
        Male
    133 50 183

    End points

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    End points reporting groups
    Reporting group title
    Avaxim® 80U Pediatric Group 1
    Reporting group description
    Infants and toddlers (≤ 23 months) received 2 injections of Avaxim® 80U Pediatric vaccine 6 months apart.

    Reporting group title
    Avaxim® 80U Pediatric Group 2
    Reporting group description
    Children (aged 2 to 11 years) and adolescents (aged 12 to 15 years) received 2 injections of Avaxim® 80U Pediatric vaccine.

    Primary: Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions After Any Vaccination with AVAXIM™ 80U-Pediatric Vaccine

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions After Any Vaccination with AVAXIM™ 80U-Pediatric Vaccine [1]
    End point description
    Solicited inj. site reactions: Tenderness, Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability, Headache, Malaise, and Myalgia. Grade 3 inj. site reactions: Tenderness (≤ 23 months), Cries when injected limb is moved or the movement of the injected limb is reduced; Pain (2 to 11 years), Incapacitating, unable to perform usual activities; Pain (≥ 12 years), Significant, prevents daily activity; Erythema and Swelling (China Food and Drug Administration; CFDA), > 30 mm. Grade 3 systemic reactions (≤ 23 months): Fever (CFDA), > 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable. Grade 3 systemic reactions (≥ 2 years): Fever (CFDA), > 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-any dose
    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 groups and the study vaccine administered for this outcome.
    End point values
    Avaxim® 80U Pediatric Group 1 Avaxim® 80U Pediatric Group 2
    Number of subjects analysed
    268
    84
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    16.4
    0
        Grade 3 Injection site Tenderness
    0
    0
        Any Injection site Pain
    0
    33.3
        Grade 3 Injection site Pain
    0
    0
        Any Injection site Erythema
    3.4
    3.6
        Grade 3 Injection site Erythema
    0
    0
        Any Injection site Swelling
    1.9
    3.6
        Grade 3 Injection site Swelling
    0
    1.2
        Any Fever
    12.7
    2.4
        Grade 3 Fever
    1.5
    0
        Any Vomiting
    3.4
    0
        Grade 3 Vomiting
    0.4
    0
        Any Crying abnormal
    8.2
    0
        Grade 3 Crying abnormal
    0.4
    0
        Any Drowsiness
    7.1
    0
        Grade 3 Drowsiness
    0
    0
        Any Appetite lost
    8.2
    0
        Grade 3 Appetite lost
    0.7
    0
        Any Irritability
    10.1
    0
        Grade 3 Irritability
    0.4
    0
        Any Headache
    0
    8.3
        Grade 3 Headache
    0
    0
        Any Malaise
    0
    15.5
        Grade 3 Malaise
    0
    0
        Any Myalgia
    0
    15.5
        Grade 3 Myalgia
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions After First Dose Vaccination with AVAXIM™ 80U-Pediatric Vaccine

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions After First Dose Vaccination with AVAXIM™ 80U-Pediatric Vaccine [2]
    End point description
    Solicited inj. site reactions: Tenderness, Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability, Headache, Malaise, and Myalgia. Grade 3 inj. site reactions: Tenderness (≤ 23 months), Cries when injected limb is moved or the movement of the injected limb is reduced; Pain (2 to 11 years), Incapacitating, unable to perform usual activities; Pain (≥ 12 years), Significant, prevents daily activity; Erythema and Swelling (China Food and Drug Administration; CFDA), > 30 mm. Grade 3 systemic reactions (≤ 23 months): Fever (CFDA), > 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable. Grade 3 systemic reactions (≥ 2 years): Fever (CFDA), > 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-dose 1
    Notes
    [2] - 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 groups and the study vaccine administered for this outcome.
    End point values
    Avaxim® 80U Pediatric Group 1 Avaxim® 80U Pediatric Group 2
    Number of subjects analysed
    268
    84
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    11.2
    0
        Grade 3 Injection site Tenderness
    0
    0
        Any Injection site Pain
    0
    25
        Grade 3 Injection site Pain
    0
    0
        Any Injection site Erythema
    3.4
    3.6
        Grade 3 Injection site Erythema
    0
    0
        Any Injection site Swelling
    1.9
    3.6
        Grade 3 Injection site Swelling
    0
    1.2
        Any Fever
    11.9
    2.4
        Grade 3 Fever
    1.5
    0
        Any Vomiting
    2.6
    0
        Grade 3 Vomiting
    0.4
    0
        Any Crying abnormal
    8.2
    0
        Grade 3 Crying abnormal
    0.4
    0
        Any Drowsiness
    6.3
    0
        Grade 3 Drowsiness
    0
    0
        Any Appetite lost
    7.8
    0
        Grade 3 Appetite lost
    0.7
    0
        Any Irritability
    9.3
    0
        Grade 3 Irritability
    0.4
    0
        Any Headache
    0
    6
        Grade 3 Headache
    0
    0
        Any Malaise
    0
    10.7
        Grade 3 Malaise
    0
    0
        Any Myalgia
    0
    8.3
        Grade 3 Myalgia
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions After Second Dose Vaccination with AVAXIM™ 80U-Pediatric Vaccine

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site and Systemic Reactions After Second Dose Vaccination with AVAXIM™ 80U-Pediatric Vaccine [3]
    End point description
    Solicited inj. site reactions: Tenderness, Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability, Headache, Malaise, and Myalgia. Grade 3 inj. site reactions: Tenderness (≤ 23 months), Cries when injected limb is moved or the movement of the injected limb is reduced; Pain (2 to 11 years), Incapacitating, unable to perform usual activities; Pain (≥ 12 years), Significant, prevents daily activity; Erythema and Swelling (China Food and Drug Administration; CFDA), > 30 mm. Grade 3 systemic reactions (≤ 23 months): Fever (CFDA), > 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds or refuses most feeds; Irritability, Inconsolable. Grade 3 systemic reactions (≥ 2 years): Fever (CFDA), > 39.0°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-dose 2
    Notes
    [3] - 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 groups and the study vaccine administered for this outcome.
    End point values
    Avaxim® 80U Pediatric Group 1 Avaxim® 80U Pediatric Group 2
    Number of subjects analysed
    256
    75
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    5.9
    0
        Grade 3 Injection site Tenderness
    0
    0
        Any Injection site Pain
    0
    18.7
        Grade 3 Injection site Pain
    0
    0
        Any Injection site Erythema
    0
    0
        Grade 3 Injection site Erythema
    0
    0
        Any Injection site Swelling
    0
    0
        Grade 3 Injection site Swelling
    0
    0
        Any Fever
    1.2
    0
        Grade 3 Fever
    0
    0
        Any Vomiting
    0.8
    0
        Grade 3 Vomiting
    0
    0
        Any Crying abnormal
    0.4
    0
        Grade 3 Crying abnormal
    0
    0
        Any Drowsiness
    0.8
    0
        Grade 3 Drowsiness
    0
    0
        Any Appetite lost
    0.4
    0
        Grade 3 Appetite lost
    0
    0
        Any Irritability
    0.8
    0
        Grade 3 Irritability
    0
    0
        Any Headache
    0
    2.7
        Grade 3 Headache
    0
    0
        Any Malaise
    0
    5.3
        Grade 3 Malaise
    0
    0
        Any Myalgia
    0
    8
        Grade 3 Myalgia
    0
    0
    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 from Day 0 up to Day 7 post-dose 2.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    Infants and toddlers (≤ 23 months) who received 2 injections of Avaxim® 80U Pediatric vaccine 6 months apart.

    Reporting group title
    Group 2
    Reporting group description
    Children (aged 2 to 11 years) and adolescents (aged 12 to 15 years) who received 2 injections of Avaxim® 80U Pediatric vaccine.

    Serious adverse events
    Group 1 Group 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 270 (0.00%)
    0 / 85 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group 1 Group 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 270 (16.30%)
    28 / 85 (32.94%)
    Nervous system disorders
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 270 (7.04%)
    0 / 85 (0.00%)
         occurrences all number
    19
    0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 270 (0.00%)
    7 / 85 (8.24%)
         occurrences all number
    0
    7
    General disorders and administration site conditions
    Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    44 / 270 (16.30%)
    0 / 85 (0.00%)
         occurrences all number
    44
    0
    Injection site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 270 (0.00%)
    28 / 85 (32.94%)
         occurrences all number
    0
    28
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    34 / 270 (12.59%)
    2 / 85 (2.35%)
         occurrences all number
    34
    2
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 270 (0.00%)
    13 / 85 (15.29%)
         occurrences all number
    0
    13
    Psychiatric disorders
    Crying abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 270 (8.15%)
    0 / 85 (0.00%)
         occurrences all number
    22
    0
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 270 (10.00%)
    0 / 85 (0.00%)
         occurrences all number
    27
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 270 (0.00%)
    13 / 85 (15.29%)
         occurrences all number
    0
    13
    Metabolism and nutrition disorders
    Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 270 (8.15%)
    0 / 85 (0.00%)
         occurrences all number
    22
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2014
    Clarification of interim/preliminary statistical analyses and timelines.

    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.
    A sponsor’s QC visit found 22 Diary Cards had similar handwriting. A site staff filled the cards based on discussion with the subjects. A subset analysis without the 22 subjects was done. Outcome is comparable to results of full safety analysis set.
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