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    Clinical Trial Results:
    Phase III b, open, randomised, multicenter study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-conjugated Haemophilus influenzae type b vaccine (Infanrix™ hexa) in Indian infants according to a 6-10-14 week schedule, when compared to Infanrix™ hexa given to Indian infants according to a 2-4-6 month schedule.

    Summary
    EudraCT number
    		 2012-002426-70
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Aug 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Apr 2016
    First version publication date
    24 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    104005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00316147
    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, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, 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?
    Yes
    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
    16 Apr 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Aug 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the antibody response to pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and poliovirus types 1, 2, 3 after a three-dose primary vaccination course with Infanrix hexa.
    Protection of trial subjects
    The vaccines were to be observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Dec 2005
    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
    India: 224
    Worldwide total number of subjects
    224
    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)
    224
    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
    		 -

    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
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infanrix hexa Group A
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection in the upper lateral quadrant of the thigh at 6, 10 and 14 weeks of age.

    Arm title
    		 Infanrix hexa Group B
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection in the upper lateral quadrant of the thigh at 2, 4 and 6 months of age.

    Number of subjects in period 1
    		Infanrix hexa Group A Infanrix hexa Group B
    Started
    112
    112
    Completed
    109
    107
    Not completed
    3
    5
         Consent withdrawn by subject
    2
    1
         Migrated/moved from study area
    1
    3
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix hexa Group A
    Reporting group description
    		 -

    Reporting group title
    Infanrix hexa Group B
    Reporting group description
    		 -

    Reporting group values
    		 Infanrix hexa Group A Infanrix hexa Group B Total
    Number of subjects
    		 112 112 224
    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: weeks
        arithmetic mean (standard deviation)
    		 6.9 ( 1.16 ) 6.8 ( 0.95 ) -
    Gender categorical
    Units: Subjects
        Female
    		 53 53 106
        Male
    		 59 59 118

    End points

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    End points reporting groups
    Reporting group title
    Infanrix hexa Group A
    Reporting group description
    		 -

    Reporting group title
    Infanrix hexa Group B
    Reporting group description
    		 -

    Primary: Vaccine response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN).

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    End point title
    		 Vaccine response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN). [1]
    End point description
    Vaccine response was defined as appearance of antibodies following vaccination (i.e., post- vaccination antibody concentration ≥ the assay cut-off) for initially sero-negative subjects. For initially sero-positive subjects, response is defined as post vaccination concentration at least equal to concentration before vaccination (post-vaccination concentration ≥ pre vaccination concentration). Immunogenicity analyses could not be performed due to inadvertent contamination of blood samples.
    End point type
    Primary
    End point timeframe
    One month after the third 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix hexa Group A Infanrix hexa Group B
    Number of subjects analysed
    112
    112
    Units: Subjects
        Anti-PT
    0
    0
        Anti-FHA
    0
    0
        Anti-PRN
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local symptoms.

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    End point title
    		 Number of subjects reporting any solicited local symptoms.
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) post-vaccination period.
    End point values
    		 Infanrix hexa Group A Infanrix hexa Group B
    Number of subjects analysed
    111
    110
    Units: Subjects
        Any Pain, D1
    55
    46
        Any Redness, D1
    24
    35
        Any Swelling, D1
    29
    26
        Any Pain, D2
    50
    42
        Any Redness, D2
    21
    29
        Any Swelling, D2
    34
    31
        Any Pain, D3
    38
    38
        Any Redness, D3
    16
    27
        Any Swelling, D3
    25
    26
        Any Pain, Overall
    66
    63
        Any Redness, Overall
    38
    52
        Any Swelling, Overall
    47
    44
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited general symptoms.

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    End point title
    		 Number of subjects reporting any solicited general symptoms.
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) post-vaccination period.
    End point values
    		 Infanrix hexa Group A Infanrix hexa Group B
    Number of subjects analysed
    110
    110
    Units: Subjects
        Any Drowsiness, D1
    19
    22
        Any Fever (Axillary), D1
    21
    20
        Any Irritability, D1
    26
    31
        Any Loss of appetite, D1
    14
    13
        Any Drowsiness, D2
    14
    21
        Any Fever (Axillary), D2
    26
    27
        Any Irritability, D2
    31
    28
        Any Loss of appetite, D2
    7
    15
        Any Drowsiness, D3
    9
    13
        Any Fever (Axillary), D3
    17
    23
        Any Irritability, D3
    20
    28
        Any Loss of appetite, D3
    6
    13
        Any Drowsiness, Overall
    26
    36
        Any Fever (Axillary), Overall
    51
    44
        Any Irritability, Overall
    44
    48
        Any Loss of appetite, Overall
    19
    28
    No statistical analyses for this end point

    Secondary: 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).
    End point description
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0-30) period after vaccination.
    End point values
    		 Infanrix hexa Group A Infanrix hexa Group B
    Number of subjects analysed
    112
    112
    Units: Subjects
        Any AE(s)
    30
    18
    No statistical analyses for this end point

    Secondary: 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).
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period.
    End point values
    		 Infanrix hexa Group A Infanrix hexa Group B
    Number of subjects analysed
    112
    112
    Units: Subjects
        Any SAE(s)
    3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited local an general symptoms: during the 4-day (Day 0–3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Day 0-30) period after vaccination; Serious adverse events (SAEs): During the entire study period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Infanrix hexa Group A
    Reporting group description
    		 -

    Reporting group title
    Infanrix hexa Group B
    Reporting group description
    		 -

    Serious adverse events
    		 Infanrix hexa Group A Infanrix hexa Group B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 112 (2.68%)
    6 / 112 (5.36%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix hexa Group A Infanrix hexa Group B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 112 (58.93%)
    63 / 112 (56.25%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    66 / 111 (59.46%)
    63 / 110 (57.27%)
         occurrences all number
    66
    63
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    38 / 111 (34.23%)
    52 / 110 (47.27%)
         occurrences all number
    38
    52
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    47 / 111 (42.34%)
    44 / 110 (40.00%)
         occurrences all number
    47
    44
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    26 / 111 (23.42%)
    36 / 110 (32.73%)
         occurrences all number
    26
    36
    Fever (Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    51 / 111 (45.95%)
    44 / 110 (40.00%)
         occurrences all number
    51
    44
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    44 / 111 (39.64%)
    48 / 110 (43.64%)
         occurrences all number
    44
    48
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    19 / 111 (17.12%)
    28 / 110 (25.45%)
         occurrences all number
    19
    28
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 112 (6.25%)
    7 / 112 (6.25%)
         occurrences all number
    7
    7
    Nasopharyngitis
         subjects affected / exposed
    8 / 112 (7.14%)
    0 / 112 (0.00%)
         occurrences all number
    8
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.

    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
    For support, Contact us.
    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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