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    Clinical Trial Results:
    A phase III, single-group, open-label, multicentre study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine Infanrix-IPV+Hib administered as a booster vaccine dose in healthy Vietnamese toddlers.

    Summary
    EudraCT number
    		 2013-002538-18
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 Apr 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Sep 2018
    First version publication date
    03 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections of the full study results.

    Trial information

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    Trial identification
    Sponsor protocol code
    115389
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01577732
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.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
    06 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and reactogenicity of the study vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs).
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Dec 2012
    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
    Vietnam: 321
    Worldwide total number of subjects
    321
    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)
    321
    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
    		 321 subjects were screened and allocated a subject number for the study, out of which 300 participated in the study and received the study vaccination.

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

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

    Arms
    Arm title
    		 Infanrix-IPV+Hib Group
    Arm description
    		 Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix-IPV+Hib
    Investigational medicinal product code
    Other name
    DTPa-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh, at 12-14 months of age.

    Number of subjects in period 1 [1]
    		Infanrix-IPV+Hib Group
    Started
    300
    Completed
    300
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 321 subjects were screened and allocated a subject number for the study, out of which 300 participated in the study and received the study vaccination.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix-IPV+Hib Group
    Reporting group description
    		 Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.

    Reporting group values
    		 Infanrix-IPV+Hib Group Total
    Number of subjects
    		 300 300
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 15.8 ( 2.96 ) -
    Gender categorical
    Units: Subjects
        Female
    		 143 143
        Male
    		 157 157

    End points

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    End points reporting groups
    Reporting group title
    Infanrix-IPV+Hib Group
    Reporting group description
    		 Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.

    Primary: Number of subjects reporting solicited local symptoms

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    End point title
    		 Number of subjects reporting solicited local symptoms [1]
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
    End point type
    Primary
    End point timeframe
    Within the 4-day (Days 0-3) follow up period after vaccination.
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix-IPV+Hib Group
    Number of subjects analysed
    300
    Units: Subjects
        Any Pain
    95
        Any Redness
    82
        Any Swelling
    52
    No statistical analyses for this end point

    Primary: Number of subjects reporting solicited general symptoms

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    End point title
    		 Number of subjects reporting solicited general symptoms [2]
    End point description
    Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.
    End point type
    Primary
    End point timeframe
    Within the 4-day (Days 0-3) follow up period after vaccination.
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix-IPV+Hib Group
    Number of subjects analysed
    300
    Units: Subjects
        Any Drowsiness
    52
        Any Irritability/fussiness
    108
        Any Loss of appetite
    115
        Any Fever
    101
    No statistical analyses for this end point

    Primary: Number of subjects reporting any unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs) [3]
    End point description
    An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
    End point type
    Primary
    End point timeframe
    Within the 31-day (Days 0-30) follow up period after vaccination.
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix-IPV+Hib Group
    Number of subjects analysed
    300
    Units: Subjects
        Any AE(s)
    107
    No statistical analyses for this end point

    Primary: Number of subjects reporting any serious adverse events (SAEs)

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs) [4]
    End point description
    SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
    End point type
    Primary
    End point timeframe
    During the entire study period (Days 0-30).
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix-IPV+Hib Group
    Number of subjects analysed
    300
    Units: Subjects
        Any SAE(s)
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: 4-day (Days 0-3) follow-up period after booster vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after booster vaccination; SAEs: during the entire study period (Days 0-30).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Infanrix-IPV+Hib Group
    Reporting group description
    		 Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib. The vaccine was administered intramuscularly in the anterolateral side of the thigh.

    Serious adverse events
    		 Infanrix-IPV+Hib Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 300 (0.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix-IPV+Hib Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    211 / 300 (70.33%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    95 / 300 (31.67%)
         occurrences all number
    95
    Redness
         subjects affected / exposed
    82 / 300 (27.33%)
         occurrences all number
    82
    Swelling
         subjects affected / exposed
    52 / 300 (17.33%)
         occurrences all number
    52
    Drowsiness
         subjects affected / exposed
    52 / 300 (17.33%)
         occurrences all number
    52
    Irritability/fussiness
         subjects affected / exposed
    108 / 300 (36.00%)
         occurrences all number
    108
    Loss of appetite
         subjects affected / exposed
    115 / 300 (38.33%)
         occurrences all number
    115
    Fever
         subjects affected / exposed
    101 / 300 (33.67%)
         occurrences all number
    101
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    48 / 300 (16.00%)
         occurrences all number
    48

    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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