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    Clinical Trial Results:
    Immunogenicity and Safety of Fractional Booster Dose of sanofi pasteur’s Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intradermally versus Full Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intramuscularly at 15 to 18 Months of Age in Healthy Toddlers in The Philippines

    Summary
    EudraCT number
    		 2015-005184-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Jul 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    IPV26
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00885157
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Franchise Medical Director, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.Vidor@sanofipasteur.com
    Scientific contact
    Franchise Medical Director, Sanofi Pasteur SA, 33 4 37 65 67 99, Emmanuel.Vidor@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
    11 Jan 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To describe in each group the immunogenicity of IMOVAX Polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25 study
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized 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
    		 This study was designed to assess the immunogenicity and safety of a fractional booster dose of IMOVAX Polio administered intradermally, compared to a full booster dose of IMOVAX Polio administered intramuscularly, at 15 to 18 months of age, after a three-dose primary vaccination series during the IPV25 study.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    07 Apr 2009
    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
    Philippines: 225
    Worldwide total number of subjects
    225
    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)
    225
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    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 07 April 2009 to 25 June 2009 at 1 clinic center in the Philippines.

    Pre-assignment
    Screening details
    		 A total of 225 subjects who met all inclusion and none of the exclusion criteria were enrolled and vaccinated in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fractional Dose of IMOVAX Polio™
    Arm description
    		 Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally as primary vaccination series (IPV25) and received a fractional booster dose (0.1 mL or 1/5 of full dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPV (IMOVAX Polio™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, intradermal into the right upper arm using the Mantoux technique, 1 booster dose.

    Arm title
    		 Full Dose of IMOVAX Polio™
    Arm description
    		 Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly as primary vaccination series (IPV25) and received a full booster dose (0.5mL) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    IPV (IMOVAX Polio™)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intradermal into the anterolateral, 1 booster dose.

    Number of subjects in period 1
    		Fractional Dose of IMOVAX Polio™ Full Dose of IMOVAX Polio™
    Started
    113
    112
    Completed
    113
    111
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fractional Dose of IMOVAX Polio™
    Reporting group description
    		 Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally as primary vaccination series (IPV25) and received a fractional booster dose (0.1 mL or 1/5 of full dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age.

    Reporting group title
    Full Dose of IMOVAX Polio™
    Reporting group description
    		 Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly as primary vaccination series (IPV25) and received a full booster dose (0.5mL) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age.

    Reporting group values
    		 Fractional Dose of IMOVAX Polio™ Full Dose of IMOVAX Polio™ Total
    Number of subjects
    		 113 112 225
    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)
    		 113 112 225
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 15.8 ± 0.7 15.8 ± 0.8 -
    Gender categorical
    Units: Subjects
        Female
    		 55 70 125
        Male
    		 58 42 100

    End points

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    End points reporting groups
    Reporting group title
    Fractional Dose of IMOVAX Polio™
    Reporting group description
    		 Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally as primary vaccination series (IPV25) and received a fractional booster dose (0.1 mL or 1/5 of full dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age.

    Reporting group title
    Full Dose of IMOVAX Polio™
    Reporting group description
    		 Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly as primary vaccination series (IPV25) and received a full booster dose (0.5mL) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age.

    Primary: Percentage of Infant Subjects with Anti-Poliovirus 1, 2 and 3 Titers of 1 ≥4 (1/dil) or 1 ≥8 (1/dil) Before and Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Percentage of Infant Subjects with Anti-Poliovirus 1, 2 and 3 Titers of 1 ≥4 (1/dil) or 1 ≥8 (1/dil) Before and Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [1]
    End point description
    Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
    End point type
    Primary
    End point timeframe
    Pre- and Post-booster
    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
    		 Fractional Dose of IMOVAX Polio™ Full Dose of IMOVAX Polio™
    Number of subjects analysed
    111
    111
    Units: Percentage of subjects
    number (not applicable)
        Anti-Polio 1; Pre-Booster; ≥ 4 (1/dil)
    100
    100
        Anti-Polio 1; Post-Booster; ≥ 4 (1/dil)
    100
    100
        Anti-Polio 1; Pre-Booster; ≥ 8 (1/dil)
    95.5
    100
        Anti-Polio 1; Post-Booster; ≥ 8 (1/dil)
    100
    100
        Anti-Polio 2; Pre-Booster; ≥ 4 (1/dil)
    98.2
    100
        Anti-Polio 2; Post-Booster; ≥ 4 (1/dil)
    100
    100
        Anti-Polio 2; Pre-Booster; ≥ 8 (1/dil)
    95.5
    98.2
        Anti-Polio 2; Post-Booster; ≥ 8 (1/dil)
    100
    100
        Anti-Polio 3; Pre-Booster; ≥ 4 (1/dil)
    97.3
    99.1
        Anti-Polio 3; Post-Booster; ≥ 4 (1/dil)
    100
    100
        Anti-Polio 3; Pre-Booster; ≥ 8 (1/dil)
    88.3
    96.4
        Anti-Polio 3; Post-Booster; ≥ 8 (1/dil)
    100
    100
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Before and Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Geometric Mean Titers of Anti-Polio 1, 2, and 3 Antibodies Before and Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [2]
    End point description
    Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
    End point type
    Primary
    End point timeframe
    Pre- and Post-booster
    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
    		 Fractional Dose of IMOVAX Polio™ Full Dose of IMOVAX Polio™
    Number of subjects analysed
    111
    111
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Polio 1; Pre-Booster
    48.2 (38.7 to 59.9)
    109.8 (84.3 to 143.2)
        Anti-Polio 1; Post-Booster
    2833.7 (2392.2 to 3356.7)
    6666.5 (5613.7 to 7916.6)
        Anti-Polio 2; Pre-Booster
    94 (65.8 to 134.2)
    132.5 (98.4 to 178.3)
        Anti-Polio 2; Post-Booster
    3210.7 (2672.5 to 3857.1)
    6522.3 (5540.6 to 7678.1)
        Anti-Polio 3; Pre-Booster
    50.3 (37.6 to 67.4)
    136.7 (103 to 181.3)
        Anti-Polio 3; Post-Booster
    4498.2 (3608.3 to 5607.5)
    11952.7 (10046.8 to 14220.1)
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Geometric Mean Titer Ratios of Anti-Polio 1, 2, and 3 Antibodies Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [3]
    End point description
    Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
    End point type
    Primary
    End point timeframe
    Post-/Pre-Booster
    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
    		 Fractional Dose of IMOVAX Polio™ Full Dose of IMOVAX Polio™
    Number of subjects analysed
    111
    111
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        Anti-Polio 1
    58.8 (44.9 to 77)
    60.7 (45.7 to 80.7)
        Anti-Polio 2
    34.2 (23.9 to 48.9)
    49.2 (35.1 to 69)
        Anti-Polio 3
    89.4 (62.8 to 127.1)
    87.4 (63.2 to 121)
    No statistical analyses for this end point

    Primary: Percentage of Infant Subjects with ≥4-fold increase of Anti-Polio 1, 2, and 3 Antibodies Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Percentage of Infant Subjects with ≥4-fold increase of Anti-Polio 1, 2, and 3 Antibodies Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [4]
    End point description
    Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
    End point type
    Primary
    End point timeframe
    Post-booster
    Notes
    [4] - 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
    		 Fractional Dose of IMOVAX Polio™ Full Dose of IMOVAX Polio™
    Number of subjects analysed
    111
    111
    Units: Percentage of subjects
    number (not applicable)
        Anti-Polio 1
    95.5
    96.4
        Anti-Polio 2
    83.8
    88.3
        Anti-Polio 3
    94.6
    94.6
    No statistical analyses for this end point

    Primary: Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™)

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    End point title
    		 Percentage of Infant Subjects with Solicited Injection-site and Systemic Reactions Following Vaccination with Either A Fractional Booster-Dose Or A Full Booster-Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) [5]
    End point description
    Solicited Injection site reactions: Tenderness, Erythema, Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Solicited Injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited systemic reactions: Fever, > 39.5°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/meals or refuses most feeds/meals; Irritability, Inconsolable.
    End point type
    Primary
    End point timeframe
    Day 0 to Day 7 post-booster
    Notes
    [5] - 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
    		 Fractional Dose of IMOVAX Polio™ Full Dose of IMOVAX Polio™
    Number of subjects analysed
    113
    112
    Units: Percentage of subjects
    number (not applicable)
        Any Injection site Tenderness
    28.6
    21.2
        Grade 3 Injection site Tenderness
    0
    0
        Any Injection site Erythema
    38.4
    11.5
        Grade 3 Injection site Erythema
    0
    0
        Any Injection site Swelling
    8.9
    1.8
        Grade 3 Injection site Swelling
    0
    0
        Any Fever
    8
    15
        Grade 3 Fever
    0.9
    0.9
        Any Vomiting
    3.6
    5.3
        Grade 3 Vomiting
    0
    0
        Any Crying abnormal
    2.7
    3.5
        Grade 3 Crying abnormal
    0
    0
        Any Drowsiness
    5.4
    8
        Grade 3 Drowsiness
    0
    0
        Any Appetite lost
    8
    7.1
        Grade 3 Appetite lost
    0
    0
        Any Irritability
    6.3
    9.7
        Grade 3 Irritability
    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-booster vaccine injection.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Fractional Dose of IMOVAX Polio™
    Reporting group description
    		 Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally as primary vaccination series (IPV25) and received a fractional booster dose (0.1 mL or 1/5 of full dose) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intradermally between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age.

    Reporting group title
    Full Dose of IMOVAX Polio™
    Reporting group description
    		 Toddlers received Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly as primary vaccination series (IPV25) and received a full booster dose (0.5mL) of Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) intramuscularly between 15 and 18 months of age. Toddlers also received concomitant DTw-Hib vaccine (TETRAct-HIb®) between 12 and 24 months of age.

    Serious adverse events
    		 Fractional Dose of IMOVAX Polio™ Full Dose of IMOVAX Polio™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 112 (1.79%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fractional Dose of IMOVAX Polio™ Full Dose of IMOVAX Polio™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 112 (49.11%)
    36 / 112 (32.14%)
    Nervous system disorders
    Any Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 112 (5.36%)
    9 / 112 (8.04%)
         occurrences all number
    6
    9
    General disorders and administration site conditions
    Any Injection site Tenderness
    alternative assessment type: Systematic
         subjects affected / exposed
    32 / 112 (28.57%)
    24 / 112 (21.43%)
         occurrences all number
    32
    24
    Any Injection site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    43 / 112 (38.39%)
    13 / 112 (11.61%)
         occurrences all number
    43
    13
    Any Injection site Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 112 (8.93%)
    2 / 112 (1.79%)
         occurrences all number
    10
    2
    Any Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 112 (8.04%)
    17 / 112 (15.18%)
         occurrences all number
    9
    17
    Gastrointestinal disorders
    Any Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 112 (3.57%)
    6 / 112 (5.36%)
         occurrences all number
    4
    6
    Psychiatric disorders
    Any Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 112 (6.25%)
    11 / 112 (9.82%)
         occurrences all number
    7
    11
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    34 / 112 (30.36%)
    36 / 112 (32.14%)
         occurrences all number
    41
    42
    Metabolism and nutrition disorders
    Any Appetite lost
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 112 (8.04%)
    8 / 112 (7.14%)
         occurrences all number
    9
    8

    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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