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    Clinical Trial Results:
    A phase III, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) administered to Indian infants according to a 6-10-14 weeks schedule and a 2-4-6 months schedule.

    Summary
    EudraCT number
    		 2013-003427-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Feb 2013

    Results information
    Results version number
    		 v3(current)
    This version publication date
    18 Oct 2020
    First version publication date
    30 May 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    111157
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01353703
    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?
    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
    16 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunological response to the study vaccine in terms of seroprotection status for diphtheria, tetanus, polio, hepatitis B and Hib antigens, and in terms of vaccine response for the pertussis, one month after the third dose of the primary vaccination.
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration 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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Apr 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
    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 6-10-14 Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of Infanrix hexa were administered by injection intramuscularly into the right side of the thigh, at 6, 10 and 14 weeks of age.

    Arm title
    		 Infanrix Hexa 2-4-6 Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses of Infanrix hexa were administered by injection intramuscularly into the right side of the thigh, at 2, 4 and 6 months of age.

    Number of subjects in period 1
    		Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Started
    112
    112
    Completed
    111
    112
    Not completed
    1
    0
         Migrated/moved from study area
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix Hexa 6-10-14 Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix Hexa 2-4-6 Group
    Reporting group description
    		 -

    Reporting group values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group 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)
    		 6.7 ± 1.04 6.8 ± 1.13 -
    Gender categorical
    Units: Subjects
        Female
    		 52 52 104
        Male
    		 60 60 120

    End points

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    End points reporting groups
    Reporting group title
    Infanrix Hexa 6-10-14 Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix Hexa 2-4-6 Group
    Reporting group description
    		 -

    Primary: Number of seroprotected subjects against anti-diphteria (anti-D) and anti-tetanus (anti-T) antigens

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    End point title
    		 Number of seroprotected subjects against anti-diphteria (anti-D) and anti-tetanus (anti-T) antigens [1]
    End point description
    A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 0.1 international units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    One month post Dose 3
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    105
    106
    Units: Subjects
        Anti-D, [N=105;106]
    105
    106
        Anti-T, [N=105;106]
    105
    106
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-hepatitis B (anti-HBs) antigens

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    End point title
    		 Number of seroprotected subjects against anti-hepatitis B (anti-HBs) antigens [2]
    End point description
    A seroprotected subject is defined as a vaccinated subject with anti-HBs antibody concentration ≥ 10 miliinternational units per milliliter (mIU/mL)
    End point type
    Primary
    End point timeframe
    One month post Dose 3
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    101
    105
    Units: Subjects
        Anti-HBs, [N=101;105]
    101
    104
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-poliovirus (anti-Polio) types 1, 2, 3 antigens

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    End point title
    		 Number of seroprotected subjects against anti-poliovirus (anti-Polio) types 1, 2, 3 antigens [3]
    End point description
    Seroprotection is defined as anti-Poliovirus 1, 2 and 3 antibody titres ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50)
    End point type
    Primary
    End point timeframe
    One month post Dose 3
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    99
    99
    Units: Subjects
        Anti-Polio 1, [N=99;99]
    99
    99
        Anti-Polio 2, [N=77;88]
    77
    88
        Anti-Polio 3, [N=74;79]
    73
    79
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against anti-polyribosyl-ribitol phosphate (anti-PRP) antigens

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    End point title
    		 Number of seroprotected subjects against anti-polyribosyl-ribitol phosphate (anti-PRP) antigens [4]
    End point description
    Seroprotection is defined as antibody concentration ≥ 0.15 micrograms per millilitre (µg/mL)
    End point type
    Primary
    End point timeframe
    One month post Dose 3
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    105
    106
    Units: Subjects
        Anti-PRP, [N=105;106]
    104
    105
    No statistical analyses for this end point

    Primary: Number of subjects with vaccine response for pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)

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    End point title
    		 Number of subjects with vaccine response for pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) [5]
    End point description
    Vaccine response defined as : For initially seronegative subjects, antibody concentration ≥ 5 ELU/mL at 1 month after third dose. For initially seropositive subjects: antibody concentration at 1 month after third dose ≥ 1 fold increase the pre-vaccination antibody concentration.
    End point type
    Primary
    End point timeframe
    One month post Dose 3
    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: This outcome was descriptive; hence no statistical analyses were required.
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    89
    90
    Units: Subjects
        Anti-PT, S- [N=61;67]
    61
    67
        Anti-PT, S+ [N=44;37]
    44
    36
        Anti-FHA, S- [N=12;12]
    12
    12
        Anti-FHA, S+ [N=89;90]
    86
    88
        Anti-PRN, S- [N=86;89]
    86
    89
        Anti-PRN, S+ [N=19;15]
    18
    14
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post vaccination, after each dose
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    111
    112
    Units: Subjects
        Any Pain, D1 [N=111,112]
    23
    11
        Any Redness, D1 [N=111,112]
    3
    1
        Any Swelling, D1 [N=111,112]
    7
    4
        Any Pain, D2 [N=111,112]
    13
    3
        Any Redness, D2 [N=111,112]
    0
    1
        Any Swelling, D2 [N=111,112]
    2
    2
        Any Pain, D3 [N=111,112]
    10
    6
        Any Redness, D3 [N=111,112]
    3
    0
        Any Swelling, D3 [N=111,112]
    2
    3
        Any Pain, Across [N=111,112]
    28
    15
        Any Redness, Across [N=111,112]
    6
    2
        Any Swelling, Across [N=111,112]
    8
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post vaccination, after each dose
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    111
    112
    Units: Subjects
        Any Drowsiness, D1 [N=111,112]
    0
    2
        Any Irritability/fussiness, D1 [N=111,112]
    8
    5
        Any Loss of appetite, D1 [N=111,112]
    1
    3
        Any Temperature/(Axillary), D1 [N=111,112]
    10
    7
        Any Drowsiness, D2 [N=111,112]
    0
    0
        Any Irritability/fussiness, D2 [N=111,112]
    2
    5
        Any Loss of appetite, D2 [N=111,112]
    0
    1
        Any Temperature/(Axillary), D2 [N=111,112]
    5
    7
        Any Drowsiness, D3 [N=111,112]
    0
    0
        Any Irritability/fussiness, D3 [N=111,112]
    3
    3
        Any Loss of appetite, D3 [N=111,112]
    1
    1
        Any Temperature/(Axillary), D3 [N=111,112]
    3
    6
        Any Drowsiness, Across [N=111,112]
    0
    2
        Any Irritability/fussiness, Across [N=111,112]
    13
    10
        Any Loss of appetite, Across [N=111,112]
    2
    5
        Any Temperature/(Axillary), Across [N=111,112]
    17
    17
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) post vaccination
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    112
    112
    Units: Subjects
        Any AEs [N=112,112]
    40
    25
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    112
    112
    Units: Subjects
        Any SAEs [N=112,112]
    2
    3
    No statistical analyses for this end point

    Secondary: Anti-D and Anti-T antibody concentrations

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    End point title
    		 Anti-D and Anti-T antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    One month post Dose 3
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    105
    106
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D, [N=105;106]
    2.334 (2.049 to 2.659)
    3.726 (3.26 to 4.258)
        Anti-T, [N=105;106]
    3.307 (2.925 to 3.739)
    4.904 (4.378 to 5.493)
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    One month post Dose 3
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    101
    105
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, [N=101;105]
    1695.7 (1395.2 to 2060.9)
    3314.5 (2645.2 to 4153.1)
    No statistical analyses for this end point

    Secondary: Anti-Polio types 1, 2, 3 antibody titers

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    End point title
    		 Anti-Polio types 1, 2, 3 antibody titers
    End point description
    End point type
    Secondary
    End point timeframe
    One month post Dose 3
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    99
    99
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-Polio1, [N=99;99]
    884.3 (666.6 to 1173.1)
    1799.2 (1429 to 2265.5)
        Anti-Polio2, [N= 77;88]
    840.2 (616.9 to 1144.2)
    2138.7 (1658.1 to 2758.7)
        Anti-Polio3, [N= 74;79]
    923.7 (691.9 to 1233.2)
    2245.5 (1866.1 to 2702.1)
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    One month post Dose 3
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    105
    106
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP, [N=105;106]
    2.697 (2.176 to 3.343)
    5.404 (4.168 to 7.006)
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA and anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    One month post Dose 3
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    105
    106
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, [N=105;106]
    107.3 (96.6 to 119.1)
    108.2 (97.4 to 120.2)
        Anti-FHA, [N=105;106]
    293.7 (259.4 to 332.6)
    369.3 (335.5 to 406.5)
        Anti-PRN, [N=105;106]
    224.4 (194.2 to 259.3)
    243.6 (213.2 to 278.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PT, anti-FHA and anti-PRN antibodies with cut-off ≥ 5 EU/mL

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    End point title
    		 Number of subjects with anti-PT, anti-FHA and anti-PRN antibodies with cut-off ≥ 5 EU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    One month post Dose 3
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    105
    106
    Units: Subjects
        Anti-PT, [N=105;106]
    105
    106
        Anti-FHA, [N=105;106]
    105
    106
        Anti-PRN, [N=105;106]
    105
    106
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against anti-Polio 1, 2, 3 antibodies

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    End point title
    		 Number of seroprotected subjects against anti-Polio 1, 2, 3 antibodies
    End point description
    A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
    End point type
    Secondary
    End point timeframe
    At Month 0
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    97
    102
    Units: Subjects
        Anti-Polio 1, [N=97;102]
    71
    70
        Anti-Polio 2, [N=56;55]
    38
    42
        Anti-Polio 3, [N=88;91]
    23
    30
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PT, anti-FHA and anti-PRN antibodies with cut-off ≥ 5 EU/mL

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    End point title
    		 Number of subjects with anti-PT, anti-FHA and anti-PRN antibodies with cut-off ≥ 5 EU/mL
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 0
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    105
    104
    Units: Subjects
        Anti-PT, [N=105;104]
    44
    37
        Anti-FHA, [N=101;102]
    89
    90
        Anti-PRN, [N=105;104]
    19
    15
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against anti-HBs antigens

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    End point title
    		 Number of seroprotected subjects against anti-HBs antigens
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to Dose 1
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    80
    81
    Units: Subjects
        Anti-HBs, [N=80;81]
    14
    13
    No statistical analyses for this end point

    Secondary: Anti-Polio types 1, 2, 3 antibody titers

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    End point title
    		 Anti-Polio types 1, 2, 3 antibody titers
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to Dose 1
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    97
    102
    Units: Titer
    geometric mean (confidence interval 95%)
        Anti-Polio 1, [N=97;102]
    53.5 (33.5 to 85.3)
    31.9 (21.5 to 47.2)
        Anti-Polio 2, [N=56;55]
    32.5 (19.2 to 55)
    36.2 (22.2 to 59)
        Anti-Polio 3, [N=88;91]
    8 (5.9 to 10.8)
    11.9 (8.3 to 17)
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA and anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to Dose 1
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    105
    104
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, [N=105;104]
    5 (4.2 to 6)
    4.6 (3.8 to 5.6)
        Anti-FHA, [N=101;102]
    18.7 (15 to 23.3)
    20.1 (16.1 to 25.2)
        Anti-PRN, [N=105;104]
    3.4 (2.9 to 3.9)
    3.2 (2.8 to 3.7)
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to Dose 1
    End point values
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Number of subjects analysed
    80
    81
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs, [N=80;81]
    5.9 (4.2 to 8.3)
    5.6 (4.1 to 7.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 4-day post-vaccination period, Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Infanrix Hexa 6-10-14 Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix Hexa 2-4-6 Group
    Reporting group description
    		 -

    Serious adverse events
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 112 (1.79%)
    3 / 112 (2.68%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Lower respiratory tract infection
    alternative assessment type: Non-systematic
         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
    Bronchiolitis
         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
    Pneumonia
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 112 (40.18%)
    36 / 112 (32.14%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    28 / 112 (25.00%)
    15 / 112 (13.39%)
         occurrences all number
    46
    20
    Erythema
         subjects affected / exposed
    6 / 112 (5.36%)
    2 / 112 (1.79%)
         occurrences all number
    6
    2
    Swelling
         subjects affected / exposed
    8 / 112 (7.14%)
    9 / 112 (8.04%)
         occurrences all number
    11
    9
    Irritability/fussiness
         subjects affected / exposed
    13 / 112 (11.61%)
    10 / 112 (8.93%)
         occurrences all number
    13
    13
    Pyrexia
         subjects affected / exposed
    18 / 112 (16.07%)
    17 / 112 (15.18%)
         occurrences all number
    19
    20
    Infections and infestations
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 112 (16.07%)
    11 / 112 (9.82%)
         occurrences all number
    23
    13
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 112 (3.57%)
    6 / 112 (5.36%)
         occurrences all number
    5
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2012
    As per the request of the regulatory authorities in India, sub-group analyses will be performed based on the hepatitis B status of the mother and number of OPV doses given to the subject since birth. Also, an analysis based on the prevaccination status of anti-HBs antibodies will be performed. As these exploratory analyses are not powered to draw conclusions, the analyses will be performed for information only. • The secondary objectives and endpoints have been updated to include analysis of anti-HBs antibody concentrations before the first dose of primary vaccination. • The outline of study procedures table has been updated to include the information about the hepatitis B status of the mother based on medical history. • The names of the contributing authors have been updated in the title page. The name of the sponsor signatory has also been updated in the protocol amendment 1 sponsor signatory approval page.

    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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