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    Clinical Trial Results:
    A phase IIIb, open, randomized, controlled, multicenter study to assess the co-administration of Rotarix (GlaxoSmithKline Biologicals’) with Hib-MenCY-TT (MenHibrix)(GlaxoSmithKline Biologicals’ Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) at 2 and 4 months of age, the co-administration of Prevnar 13 (Pfizer) with Hib-MenCY-TT (MenHibrix) at 2, 4 and 6 months of age and the co-administration of Prevnar 13 and Havrix (GlaxoSmithKline Biologicals’) with Hib-MenCY-TT ((MenHibrix) at 12 to 15 months of age.

    Summary
    EudraCT number
    		 2013-003459-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Mar 2016

    Results information
    Results version number
    		 v1
    This version publication date
    22 Dec 2016
    First version publication date
    22 Dec 2016
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    112931
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01978093
    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
    18 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority of 4 doses of Hib-MenCY-TT compared to 3 doses of PedvaxHIB,when co-administered with Prevnar 13 and Havrix,in terms of anti-PRP concentration Epoch 001:To demonstrate non-inferiority of •2 doses of Rotarix co-administered with Hib-MenCY-TT,Pediarix and Prevnar 13 compared to Rotarix co-administered with PedvaxHIB,Pediarix and Prevnar 13 in terms of Rotarix IgA GMCs •3 doses of Prevnar 13 co-administered with Hib-MenCY-TT,Rotarix and Pediarix compared to Prevnar 13 co-administered with PedvaxHIB,Rotarix and Pediarix in terms of S. pneumoniae GMCs Epoch 002:To demonstrate non-inferiority of •2 doses of Havrix when the 1st dose is co-administered with Hib-MenCY-TT and Prevnar 13 compared to Havrix when the 1st dose is co-administered with PedvaxHIB and Prevnar 13,at 12-15 months of age •4 doses of Prevnar 13 co-administered with Hib-MenCY-TT and Havrix compared to Prevnar 13 co-administered with PedvaxHIB and Havrix in terms of S.pneumoniae GMCs
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of the vaccines, with appropriate medical treatment readily available in case of anaphylaxis
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Feb 2014
    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
    United States: 600
    Worldwide total number of subjects
    600
    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)
    600
    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
    		 The study consists of two epochs: o Epoch 001: starting at Visit 1 (Day 0) and ending at the day preceding Visit 5 o Epoch 002: starting at Visit 5 (Month 10-13) and ending at Visit 8 (Month 17-20, 31 days after the 2nd Havrix® vaccination)

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 600
    Number of subjects completed
    		 600

    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
    		 HibCY Group
    Arm description
    		 Subjects received 4 doses of Hib-MenCY-TT (MenHibrix®) vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hib-MenCY-TT (MenHibrix)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Four doses administered intramuscularly in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13.

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two doses administered orally at Day 0 and Month 2.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two doses administered intramuscularly in the left upper anterolateral thigh at Month 10-13 and Month 16-19.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Four doses administered intramuscularly in the left lower anterolateral thigh at Day 0 and Month 2, Month 4 and Month 10-13.

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses administered intramuscularly in the left upper anterolateral thigh at Day 0 and Month 2 and in the right upper anterolateral thigh at Month 4.

    Arm title
    		 PedHIB Group
    Arm description
    		 Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Two doses administered orally at Day 0 and Month 2.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two doses administered intramuscularly in the left upper anterolateral thigh at Month 10-13 and Month 16-19.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Four doses administered intramuscularly in the left lower anterolateral thigh at Day 0 and Month 2, Month 4 and Month 10-13.

    Investigational medicinal product name
    PedvaxHIB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses administered intramuscularly in the right upper anterolateral thigh at Day 0, Month 2 and Month 10-13.

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three doses administered intramuscularly in the left upper anterolateral thigh at Day 0 and Month 2 and in the right upper anterolateral thigh at Month 4.

    Number of subjects in period 1
    		HibCY Group PedHIB Group
    Started
    297
    303
    Completed
    232
    230
    Not completed
    65
    73
         Loss of kaiser coverage
    4
    10
         Adverse event, serious fatal
    -
    5
         Consent withdrawn by subject
    29
    25
         N/A for vaccine administration
    -
    1
         Child was in care of grandmother
    -
    1
         Mother lost custody of child
    -
    1
         Migrated/moved from study area
    11
    13
         Lost kaiser health plan no contact
    1
    -
         Lost to follow-up
    11
    15
         Subject Died
    1
    -
         Protocol deviation
    8
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HibCY Group
    Reporting group description
    		 Subjects received 4 doses of Hib-MenCY-TT (MenHibrix®) vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.

    Reporting group title
    PedHIB Group
    Reporting group description
    		 Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.

    Reporting group values
    		 HibCY Group PedHIB Group Total
    Number of subjects
    		 297 303
    Age categorical
    Units: Subjects
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 1.8 ( 0.4 ) 1.9 ( 0.4 ) -
    Gender categorical
    Units:
        Female
    		 148 140 288
        Male
    		 149 163 312
    Subject analysis sets

    Subject analysis set title
    HibCY Group (Epoch 001)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The First three doses Total Vaccinated cohort (post 3rd dose of Rotarix®) included all vaccinated subjects for whom data were available, those who received at least one dose of any of the study vaccines: Hib-MenCY-TT (MenHibrix®), Pediarix®, Prevnar 13® or Rotarix® and those who had the vaccine administration documented.

    Subject analysis set title
    PedHIB Group (Epoch 001)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The First three doses Total Vaccinated cohort (post 3rd dose of Rotarix®) included all vaccinated subjects for whom data were available, those who received at least one dose of any of the study vaccines: Hib-MenCY-TT (MenHibrix®), Pediarix®, Prevnar 13® or Rotarix® and those who had the vaccine administration documented.

    Subject analysis set title
    HibCY Group (Epoch 002)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Fourth dose Total Vaccinated cohort (post 4th dose of Rotarix®) included all vaccinated subjects for whom data were available, those who received at least one dose of any of the study vaccines: Hib-MenCY-TT (MenHibrix®), Pediarix®, Prevnar 13® , Rotarix®, PedvaxHIB® or Havrix® and those who had the vaccine administration documented.

    Subject analysis set title
    PedHIB Group (Epoch 002)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Fourth dose Total Vaccinated cohort (post 4th dose of Rotarix®) included all vaccinated subjects for whom data were available, those who received at least one dose of any of the study vaccines: Hib-MenCY-TT (MenHibrix®), Pediarix®, Prevnar 13® , Rotarix®, PedvaxHIB® or Havrix® and those who had the vaccine administration documented.

    Subject analysis sets values
    		 HibCY Group (Epoch 001) PedHIB Group (Epoch 001) HibCY Group (Epoch 002) PedHIB Group (Epoch 002)
    Number of subjects
    297
    303
    248
    251
    Age categorical
    Units: Subjects
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    1.8 ( 0.4 )
    1.9 ( 0.4 )
    1.8 ( 0.4 )
    1.8 ( 0.4 )
    Gender categorical
    Units:
        Female
    148
    140
    124
    115
        Male
    149
    163
    124
    136

    End points

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    End points reporting groups
    Reporting group title
    HibCY Group
    Reporting group description
    		 Subjects received 4 doses of Hib-MenCY-TT (MenHibrix®) vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.

    Reporting group title
    PedHIB Group
    Reporting group description
    		 Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.

    Subject analysis set title
    HibCY Group (Epoch 001)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The First three doses Total Vaccinated cohort (post 3rd dose of Rotarix®) included all vaccinated subjects for whom data were available, those who received at least one dose of any of the study vaccines: Hib-MenCY-TT (MenHibrix®), Pediarix®, Prevnar 13® or Rotarix® and those who had the vaccine administration documented.

    Subject analysis set title
    PedHIB Group (Epoch 001)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The First three doses Total Vaccinated cohort (post 3rd dose of Rotarix®) included all vaccinated subjects for whom data were available, those who received at least one dose of any of the study vaccines: Hib-MenCY-TT (MenHibrix®), Pediarix®, Prevnar 13® or Rotarix® and those who had the vaccine administration documented.

    Subject analysis set title
    HibCY Group (Epoch 002)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Fourth dose Total Vaccinated cohort (post 4th dose of Rotarix®) included all vaccinated subjects for whom data were available, those who received at least one dose of any of the study vaccines: Hib-MenCY-TT (MenHibrix®), Pediarix®, Prevnar 13® , Rotarix®, PedvaxHIB® or Havrix® and those who had the vaccine administration documented.

    Subject analysis set title
    PedHIB Group (Epoch 002)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Fourth dose Total Vaccinated cohort (post 4th dose of Rotarix®) included all vaccinated subjects for whom data were available, those who received at least one dose of any of the study vaccines: Hib-MenCY-TT (MenHibrix®), Pediarix®, Prevnar 13® , Rotarix®, PedvaxHIB® or Havrix® and those who had the vaccine administration documented.

    Primary: Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values.

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    End point title
    		 Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values. [1]
    End point description
    The cut-off values were defined as a concentration equal to or above 1.0 microgram per milliliter (μg/mL).
    End point type
    Primary
    End point timeframe
    At 1 month post-dose 4 (HibCY Group) and 1 month post-dose 3 (PedHIB Group).
    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
    		 HibCY Group PedHIB Group
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Subjects
    Notes
    [2] - Results are not available yet.
    [3] - Results are not available yet.
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local adverse events (AEs) [Epoch 001]

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    End point title
    		 Number of subjects reporting solicited local adverse events (AEs) [Epoch 001]
    End point description
    Solicited local symptom assessed was pain. Any = Occurrence of the specified local symptom irrespective of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. 99999 = placeholder value for group(s) with results not being applicable/missing.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall
    End point values
    		 HibCY Group (Epoch 001) PedHIB Group (Epoch 001)
    Number of subjects analysed
    286
    295
    Units: Subjects
        Any Pain; Dose 1 (Total) [N= 285, 291]
    155
    189
        Grade 3 Pain; Dose 1 (Total) [N= 285, 291]
    13
    35
        Any Pain; Dose 1(Hib-MenCY-TT/ PedHIB) [N=285,291]
    126
    178
        Grade 3 Pain;Dose 1(Hib-MenCY-TT/PedHIB)[N=285,291
    8
    30
        Any Pain; Dose 1 (DTPa-HBV-IPV) [N= 285, 291]
    144
    167
        Grade 3 Pain; Dose 1 (DTPa-HBV-IPV) [N= 285, 291]
    11
    30
        Any Pain; Dose 1 (Prev13) [N= 285, 291]
    132
    171
        Grade 3 Pain; Dose 1 (Prev13) [N= 285, 291]
    13
    28
        Any Pain; Dose 2 (Total) [N= 272, 278]
    142
    174
        Grade 3 Pain; Dose 2 (Total) [N= 272, 278]
    12
    24
        Any Pain; Dose 2(Hib-MenCY-TT/ PedHIB)[N=272, 291]
    124
    158
        Grade 3 Pain;Dose 2(Hib-MenCY-TT/PedHIB)[N=272,291
    8
    20
        Any Pain; Dose 2 (DTPa-HBV-IPV) [N= 272, 278]
    123
    155
        Grade 3 Pain; Dose 2 (DTPa-HBV-IPV) [N=272, 278]
    11
    22
        Any Pain; Dose 2 (Prev13) [N= 272, 277]
    121
    155
        Grade 3 Pain; Dose 2 (Prev13) [N= 272, 277]
    9
    21
        Any Pain; Dose 3 (Total) [N= 262, 264]
    124
    141
        Grade 3 Pain; Dose 3 (Total) [N= 262, 264]
    12
    11
        Any Pain; Dose 3 (Hib-MenCY-TT/ PedHIB) [N=260,NA]
    101
    99999
        Grade 3 Pain;Dose 3(Hib-MenCY-TT/PedHIB)[N=260,NA]
    8
    99999
        Any Pain; Dose 3 (DTPa-HBV-IPV) [N= 262, 264]
    112
    134
        Grade 3 Pain; Dose 3 (DTPa-HBV-IPV) [N= 262, 264]
    11
    10
        Any Pain; Dose 3 (Prev13) [N= 262, 264]
    104
    126
        Grade 3 Pain; Dose 3 (Prev13) [N= 262, 264]
    11
    8
        Any Pain; Across Doses (Total) [N= 286, 295]
    209
    230
        Grade 3 Pain; Across Doses (Total) [N= 286, 295]
    28
    54
        Any Pain; Across(Hib-MenCY-TT/PedHIB) [N=286,295]
    186
    209
        Grade3Pain; Across(Hib-MenCY-TT/PedHIB)[N=286,295]
    20
    43
        Any Pain; Across Doses (DTPa-HBV-IPV) [N= 286,295]
    193
    212
        Grade 3 Pain;Across Doses(DTPa-HBV-IPV)[N=286,295]
    26
    48
        Any Pain; Across Doses (Prev13) [N= 286, 295]
    188
    217
        Grade 3 Pain; Across Doses (Prev13) [N= 286, 295]
    27
    46
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local adverse events (AEs) [Epoch 001]

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    End point title
    		 Number of subjects reporting solicited local adverse events (AEs) [Epoch 001]
    End point description
    Solicited local symptom assessed was redness. Any = Occurrence of the specified local symptom irrespective of intensity grade. Grade 3 redness = redness greater than 30 millimeters (mm) i.e. > 30mm. 99999 = placeholder value for group(s) with results not being applicable/missing.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall
    End point values
    		 HibCY Group (Epoch 001) PedHIB Group (Epoch 001)
    Number of subjects analysed
    286
    295
    Units: Subjects
        Any Redness; Dose 1 (Total) [N= 285, 291]
    92
    117
        Grade 3 Redness; Dose 1 (Total) [N= 285, 291]
    2
    2
        Any Redness;Dose 1(Hib-MenCY-TT/PedHIB)[N=285,291]
    60
    103
        Grade3Redness;Dose1(Hib-MenCY-TT/PedHIB)[N=285,291
    2
    1
        Any Redness; Dose 1 (DTPa-HBV-IPV) [N= 285, 291]
    77
    73
        Grade 3 Redness; Dose 1(DTPa-HBV-IPV)[N= 285, 291]
    0
    0
        Any Redness; Dose 1 (Prev13) [N= 285, 291]
    67
    71
        Grade 3 Rednessn; Dose 1 (Prev13) [N= 285, 291]
    0
    1
        Any Redness; Dose 2 (Total) [N= 272, 278]
    108
    145
        Grade 3 Redness; Dose 2 (Total) [N= 272, 278]
    0
    1
        Any Redness;Dose 2(Hib-MenCY-TT/PedHIB)[N=272,291]
    82
    115
        Grade3Redness;Dose2(Hib-MenCY-TT/PedHIB)[N=272,291
    0
    0
        Any Redness; Dose 2 (DTPa-HBV-IPV) [N= 272, 278]
    92
    120
        Grade 3 Rednes; Dose 2 (DTPa-HBV-IPV) [N=272, 278]
    0
    1
        Any Redness; Dose 2 (Prev13) [N= 272, 277]
    83
    114
        Grade 3 Redness; Dose 2 (Prev13) [N= 272, 277]
    0
    1
        Any Redness; Dose 3 (Total) [N= 262, 264]
    116
    145
        Grade 3 Redness; Dose 3 (Total) [N= 262, 264]
    0
    2
        Any Redness;Dose 3(Hib-MenCY-TT/PedHIB) [N=260,NA]
    82
    99999
        Grade3Redness;Dose 3(Hib-MenCY-TT/PedHIB)[N=260,NA
    0
    99999
        Any Redness; Dose 3 (DTPa-HBV-IPV) [N= 262, 264]
    100
    133
        Grade 3 Redness;Dose 3(DTPa-HBV-IPV) [N= 262, 264]
    0
    0
        Any Redness; Dose 3 (Prev13) [N= 262, 264]
    95
    121
        Grade 3 Redness; Dose 3 (Prev13) [N= 262, 264]
    0
    2
        Any Redness; Across Doses (Total) [N= 286, 295]
    165
    198
        Grade 3 Redness;Across Doses (Total) [N= 286, 295]
    2
    5
        Any Redness;Across(Hib-MenCY-TT/PedHIB)[N=286,295]
    125
    149
        Grade3Redness;Across(Hib-MenCY-TT/PedHIB)N=286,295
    2
    1
        Any Redness;Across Doses(DTPa-HBV-IPV)[N= 286,295]
    148
    181
        Grade 3 Redness;AcrossDoses(DTPa-HBV-IPV)N=286,295
    0
    1
        Any Redness; Across Doses (Prev13) [N= 286, 295]
    137
    169
        Grade 3 Redness;Across Doses (Prev13)[N= 286, 295]
    0
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local adverse events (AEs) [Epoch 001]

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    End point title
    		 Number of subjects reporting solicited local adverse events (AEs) [Epoch 001]
    End point description
    Solicited local symptom assessed was swelling. Any = Occurrence of the specified local symptom irrespective of intensity grade. Grade 3 swelling = swelling greater than 30 millimeters (mm) i.e. > 30mm. 99999 = placeholder value for group(s) with results not being applicable/missing.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall.
    End point values
    		 HibCY Group (Epoch 001) PedHIB Group (Epoch 001)
    Number of subjects analysed
    286
    295
    Units: Subjects
        Any Swelling; Dose 1 (Total) [N= 285, 291]
    70
    79
        Grade 3 Swelling; Dose 1 (Total) [N= 285, 291]
    2
    4
        Any Swelling;Dose1(Hib-MenCY-TT/PedHIB)[N=285,291]
    32
    64
        Grade3Swelling;Dose1(Hib-MenCY-TT/PedHIB)N=285,291
    1
    3
        Any Swelling; Dose 1 (DTPa-HBV-IPV) [N= 285, 291]
    53
    47
        Grade 3 Swelling;Dose 1(DTPa-HBV-IPV)[N= 285,291]
    2
    1
        Any Swelling; Dose 1 (Prev13) [N= 285, 291]
    42
    47
        Grade 3 Swelling; Dose 1 (Prev13) [N= 285, 291]
    1
    0
        Any Swelling; Dose 2 (Total) [N= 272, 278]
    77
    118
        Grade 3 Swelling; Dose 2 (Total) [N= 272, 278]
    1
    2
        Any Swelling;Dose2(Hib-MenCY-TT/PedHIB)[N=272,291]
    50
    85
        Grade3Swelling;Dose2(Hib-MenCY-TT/PedHIB)N=272,291
    1
    1
        Any Swelling; Dose 2 (DTPa-HBV-IPV) [N= 272, 278]
    60
    101
        Grade 3 Swelling;Dose 2(DTPa-HBV-IPV) [N=272, 278]
    1
    1
        Any Swelling; Dose 2 (Prev13) [N= 272, 277]
    61
    80
        Grade 3 Swelling; Dose 2 (Prev13) [N= 272, 277]
    1
    1
        Any Swelling; Dose 3 (Total) [N= 262, 264]
    92
    115
        Grade 3 Swelling; Dose 3 (Total) [N= 262, 264]
    1
    1
        Any Swelling;Dose3(Hib-MenCY-TT/PedHIB) [N=260,NA]
    50
    99999
        Grade3Swelling;Dose3(Hib-MenCY-TT/PedHIB)[N=260,NA
    0
    99999
        Any Swelling; Dose 3 (DTPa-HBV-IPV) [N= 262, 264]
    77
    100
        Grade 3 Swelling;Dose3(DTPa-HBV-IPV) [N= 262, 264]
    1
    0
        Any Swelling; Dose 3 (Prev13) [N= 262, 264]
    64
    83
        Grade 3 Swelling; Dose 3 (Prev13) [N= 262, 264]
    1
    1
        Any Swelling; Across Doses (Total) [N= 286, 295]
    128
    169
        Grade 3 Swelling;Across Doses(Total) [N= 286, 295]
    2
    7
        AnySwelling;Across(Hib-MenCY-TT/PedHIB)[N=286,295]
    81
    112
        Grade3Swelling;Across(Hib-MenCY-TTPedHIB)N=286,295
    1
    4
        Any Swelling;Across Doses(DTPa-HBV-IPV)[N=286,295]
    110
    147
        Grade 3Swelling;AcrossDoses(DTPa-HBV-IPV)N=286,295
    2
    2
        Any Swelling; Across Doses (Prev13) [N= 286, 295]
    101
    130
        Grade 3 Swelling;Across Doses(Prev13)[N= 286, 295]
    2
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general adverse events (AEs) [Epoch 001]

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    End point title
    		 Number of subjects reporting solicited general adverse events (AEs) [Epoch 001]
    End point description
    Solicited general symptom assessed was fever. Any = occurrence of the specified general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 fever = temperature greater than (>) 40.0 °C. Related fever= symptom assessed by the investigator as causally related to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall
    End point values
    		 HibCY Group (Epoch 001) PedHIB Group (Epoch 001)
    Number of subjects analysed
    286
    295
    Units: Subjects
        Any Fever; Dose 1 [N= 285, 291]
    34
    69
        Grade 3 Fever; Dose 1 [N= 285, 291]
    0
    0
        Related Fever; Dose 1 [N= 285, 291]
    32
    58
        Any Fever; Dose 2 [N= 273, 279]
    57
    85
        Grade 3 Fever; Dose 2 [N= 273, 279]
    0
    1
        Related Fever; Dose 2 [N= 273, 279]
    53
    81
        Any Fever; Dose 3 [N= 262, 265]
    44
    47
        Grade 3 Fever; Dose 3 [N= 262, 265]
    1
    1
        Related Fever; Dose 3 [N= 262, 265]
    43
    44
        Any Fever; Across Doses [N= 286, 295]
    100
    137
        Grade 3 Fever; Across Doses [N= 286, 295]
    1
    2
        Related Fever; Across Doses [N= 286, 295]
    94
    129
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general adverse events (AEs) [Epoch 001]

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    End point title
    		 Number of subjects reporting solicited general adverse events (AEs) [Epoch 001]
    End point description
    Solicited general symptom assessed was drowsiness. Any = occurrence of the specified general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Drowsiness = prevented normal activity. Related = symptom assessed by the investigator as causally related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall.
    End point values
    		 HibCY Group (Epoch 001) PedHIB Group (Epoch 001)
    Number of subjects analysed
    286
    295
    Units: Subjects
        Any Drowsiness; Dose 1 [N= 285, 291]
    185
    204
        Grade 3 Drowsiness; Dose 1 (Total) [N= 285, 291]
    13
    17
        Related Drowsiness; Dose 1 [N= 285, 291]
    178
    200
        Any Drowsiness; Dose 2 [N= 273, 279]
    148
    181
        Grade 3 Drowsiness; Dose 2 [N= 273, 279]
    8
    16
        Related Drowsiness; Dose 2 [N= 273, 279]
    141
    177
        Any Drowsiness; Dose 3 [N= 262, 265]
    128
    139
        Grade 3 Drowsiness; Dose 3 [N= 262, 265]
    7
    12
        Related Drowsiness; Dose 3 [N= 262, 265]
    122
    135
        Any Drowsiness; Across Doses [N= 286, 295]
    226
    248
        Grade 3 Drowsiness; Across Doses [N= 286, 295]
    23
    32
        Related Drowsiness; Across Doses [N= 286, 295]
    220
    245
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general adverse events (AEs) [Epoch 001]

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    End point title
    		 Number of subjects reporting solicited general adverse events (AEs) [Epoch 001]
    End point description
    Solicited general symptom assessed was irritability. Any = occurrence of the specified general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Related = symptom assessed by the investigator as causally related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall.
    End point values
    		 HibCY Group (Epoch 001) PedHIB Group (Epoch 001)
    Number of subjects analysed
    286
    295
    Units: Subjects
        Any Irritability; Dose 1 [N= 285, 291]
    203
    238
        Grade 3 Irritability; Dose 1 [N= 285, 291]
    10
    34
        Related Irritability; Dose 1 [N= 285, 291]
    196
    231
        Any Irritability; Dose 2 [N= 273, 279]
    191
    232
        Grade 3 Irritability; Dose 2 [N= 273, 279]
    22
    33
        Related Irritability; Dose 2 [N= 273, 279]
    183
    225
        Any Irritability; Dose 3 [N= 262, 265]
    173
    184
        Grade 3 Irritability; Dose 3 [N= 262, 265]
    16
    20
        Related Irritability; Dose 3 [N= 262, 265]
    166
    181
        Any Irritability; Across Doses [N= 286, 295]
    260
    280
        Grade 3 Irritability; Across Doses [N= 286, 295]
    40
    66
        Related Irritability; Across Doses [N= 286, 295]
    253
    275
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general adverse events (AEs) [Epoch 001]

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    End point title
    		 Number of subjects reporting solicited general adverse events (AEs) [Epoch 001]
    End point description
    Solicited general symptom assessed was loss of appetite. Any = occurrence of the specified general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Loss of appetite = did not eat at all. Related = symptom assessed by the investigator as causally related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period following each dose and overall.
    End point values
    		 HibCY Group (Epoch 001) PedHIB Group (Epoch 001)
    Number of subjects analysed
    286
    295
    Units: Subjects
        Any loss of appetite; Dose 1 [N= 285, 291]
    90
    123
        Grade 3 loss of appetite; Dose 1 [N= 285, 291]
    1
    2
        Related loss of appetite; Dose 1 [N= 285, 291]
    85
    115
        Any loss of appetite; Dose 2 [N= 273, 279]
    81
    88
        Grade 3 loss of appetite; Dose 2 [N= 273, 279]
    3
    1
        Related loss of appetite; Dose 2 [N= 273, 279]
    77
    87
        Any loss of appetite; Dose 3 [N= 262, 265]
    78
    76
        Grade 3 loss of appetite; Dose 3 [N= 262, 265]
    0
    3
        Related loss of appetite; Dose 3 [N= 262, 265]
    75
    71
        Any loss of appetite; Across Doses [N= 286, 295]
    156
    176
        Grade 3 loss of appetite;Across Doses[N= 286, 295]
    4
    6
        Related loss of appetite;Across Doses[N= 286, 295]
    151
    171
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local adverse events (AEs) [Epoch 002]

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    End point title
    		 Number of subjects reporting solicited local adverse events (AEs) [Epoch 002]
    End point description
    Solicited local symptom assessed was pain. Any = Occurrence of the specified local symptom irrespective of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3 post-dose 4 vaccination period
    End point values
    		 HibCY Group (Epoch 002) PedHIB Group (Epoch 002)
    Number of subjects analysed
    241
    242
    Units: Subjects
        Any Pain; Total [N= 241, 242]
    128
    144
        Grade 3 Pain; Total [N= 241, 242]
    6
    14
        Any Pain; Hib-MenCY-TT/ PedHIB [N= 241, 242]
    108
    121
        Grade 3 Pain; Hib-MenCY-TT/ PedHIB [N= 241, 242]
    3
    11
        Any Pain; DTPa-HBV-IPV [N= 241, 242]
    102
    136
        Grade 3 Pain; DTPa-HBV-IPV [N= 241, 242]
    3
    13
        Any Pain; Prev13 [N= 241, 242]
    100
    113
        Grade 3 Pain; Prev13 [N= 241, 242]
    5
    9
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local adverse events (AEs) [Epoch 002]

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    End point title
    		 Number of subjects reporting solicited local adverse events (AEs) [Epoch 002]
    End point description
    Solicited local symptom assessed was redness. Any = Occurrence of the specified local symptom irrespective of intensity grade. Grade 3 redness = redness greater than 30 millimeters (mm) i.e. > 30mm.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-dose 4 vaccination period.
    End point values
    		 HibCY Group (Epoch 002) PedHIB Group (Epoch 002)
    Number of subjects analysed
    241
    242
    Units: Subjects
        Any Redness; Total [N= 241, 242]
    126
    132
        Grade 3 Redness; Total [N= 241, 242]
    6
    3
        Any Redness; Hib-MenCY-TT/ PedHIB [N= 241, 242]
    93
    106
        Grade 3 Rednes; Hib-MenCY-TT/ PedHIB [N= 241, 242]
    0
    1
        Any Redness; DTPa-HBV-IPV [N= 241, 242]
    93
    123
        Grade 3 Redness; DTPa-HBV-IPV [N= 241, 242]
    3
    2
        Any Redness; Prev13 [N= 241, 242]
    99
    108
        Grade 3 Redness; Prev13 [N= 241, 242]
    3
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local adverse events (AEs) [Epoch 002]

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    End point title
    		 Number of subjects reporting solicited local adverse events (AEs) [Epoch 002]
    End point description
    Solicited local symptom assessed was swelling. Any = Occurrence of the specified local symptom irrespective of intensity grade. Grade 3 swelling = swelling greater than 30 millimeters (mm) i.e. > 30mm.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-dose 4 vaccination period.
    End point values
    		 HibCY Group (Epoch 002) PedHIB Group (Epoch 002)
    Number of subjects analysed
    241
    242
    Units: Subjects
        Any Swelling; Total [N= 241, 242]
    83
    100
        Grade 3 Swelling; Total [N= 241, 242]
    5
    3
        Any Swelling; Hib-MenCY-TT/ PedHIB [N= 241, 242]
    61
    63
        Grade 3 Swelling;Hib-MenCY-TT/PedHIB [N= 241, 242]
    0
    0
        Any Swelling; DTPa-HBV-IPV [N= 241, 242]
    55
    83
        Grade 3 Swelling; DTPa-HBV-IPV [N= 241, 242]
    2
    1
        Any Swelling; Prev13 [N= 241, 242]
    63
    67
        Grade 3 Swelling; Prev13 [N= 241, 242]
    3
    2
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general adverse events (AEs) [Epoch 002]

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    End point title
    		 Number of subjects reporting solicited general adverse events (AEs) [Epoch 002]
    End point description
    Solicited general symptom assessed was fever. Any = occurrence of the specified general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 fever = temperature greater than (>) 40.0 °C. Related fever= symptom assessed by the investigator as causally related to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-dose 4 vaccination period.
    End point values
    		 HibCY Group (Epoch 002) PedHIB Group (Epoch 002)
    Number of subjects analysed
    242
    241
    Units: Subjects
        Any Fever [N= 242, 241]
    23
    26
        Grade 3 Fever [N= 242, 241]
    0
    0
        Related Fever [N= 242, 241]
    20
    25
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general adverse events (AEs) [Epoch 002]

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    End point title
    		 Number of subjects reporting solicited general adverse events (AEs) [Epoch 002]
    End point description
    Solicited general symptom assessed was drowsiness. Any = occurrence of the specified general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Drowsiness = prevented normal activity. Related = symptom assessed by the investigator as causally related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-dose 4 vaccination period.
    End point values
    		 HibCY Group (Epoch 002) PedHIB Group (Epoch 002)
    Number of subjects analysed
    242
    241
    Units: Subjects
        Any Drowsiness [N= 242, 241]
    106
    117
        Grade 3 Drowsiness [N= 242, 241]
    7
    6
        Related Drowsiness [N= 242, 241]
    105
    114
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general adverse events (AEs) [Epoch 002]

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    End point title
    		 Number of subjects reporting solicited general adverse events (AEs) [Epoch 002]
    End point description
    Solicited general symptom assessed was irritability. Any = occurrence of the specified general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Irritability = crying that could not be comforted/prevented normal activity. Related = symptom assessed by the investigator as causally related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-dose 4 vaccination period.
    End point values
    		 HibCY Group (Epoch 002) PedHIB Group (Epoch 002)
    Number of subjects analysed
    242
    241
    Units: Subjects
        Any Irritability [N= 242, 241]
    159
    179
        Grade 3 Irritability [N= 242, 241]
    19
    21
        Related Irritability [N= 242, 241]
    156
    173
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general adverse events (AEs) [Epoch 002]

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    End point title
    		 Number of subjects reporting solicited general adverse events (AEs) [Epoch 002]
    End point description
    Solicited general symptom assessed was loss of appetite. Any = occurrence of the specified general symptom irrespective of intensity grade and relationship to vaccination. Grade 3 Loss of appetite = did not eat at all. Related = symptom assessed by the investigator as causally related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-dose 4 vaccination period.
    End point values
    		 HibCY Group (Epoch 002) PedHIB Group (Epoch 002)
    Number of subjects analysed
    242
    241
    Units: Subjects
        Any Loss of Appetite [N= 242, 241]
    80
    96
        Grade 3 Loss of Appetite [N= 242, 241]
    2
    2
        Related Loss of Appetite [N= 242, 241]
    80
    93
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events (AEs) [Epoch 001]

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AEs) [Epoch 001]
    End point description
    An unsolicited AE was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    End point type
    Secondary
    End point timeframe
    During post Dose 1 (Day 0) and before Visit 5 (Months 10-13).
    End point values
    		 HibCY Group (Epoch 001) PedHIB Group (Epoch 001)
    Number of subjects analysed
    297
    303
    Units: Subjects
        Any unsolicited AE(s)
    180
    171
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events (AEs) [Epoch 002]

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AEs) [Epoch 002]
    End point description
    An unsolicited AE was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    End point type
    Secondary
    End point timeframe
    Post-dose 4 (Month 10-13)
    End point values
    		 HibCY Group (Epoch 002) PedHIB Group (Epoch 002)
    Number of subjects analysed
    248
    251
    Units: Subjects
        Any unsolicited AE(s)
    99
    105
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    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 (Day 0 to Months 17-20)
    End point values
    		 HibCY Group PedHIB Group
    Number of subjects analysed
    297
    303
    Units: Subjects
        Any SAE(s)
    8
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events=entire study period (Day 0 to Months 17-20),Unsolicited AEs=post Dose 1 (Day 0) & before Visit 5 (Months 10-13) & post Dose 4(Months 11-14), solicited local & general symptoms= during the 4-day (Days 0-3) post-vaccination period.
    Adverse event reporting additional description
    The analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom screen/sheet completed). SAEs are reported by the reporting groups (i.e., HibCY Group and PedHIB Group), while frequent AEs are reported by the study epochs (i.e., Epoch 001 and 002)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    PedHIB Group
    Reporting group description
    		 Subjects received 3 doses of PedvaxHIB® vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.

    Reporting group title
    HibCY Group
    Reporting group description
    		 Subjects received 4 doses of Hib-MenCY-TT (MenHibrix®) vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix® vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix® vaccine at Day 0 and Month 2, 4 doses of Prevnar 13® vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix® vaccine at Month 10-13 and Month 16-19.

    Serious adverse events
    		 PedHIB Group HibCY Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 303 (3.63%)
    8 / 297 (2.69%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki’s disease
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Histiocytosis haematophagic
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hypothermia
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden infant death syndrome
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 297 (0.34%)
         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
    Apparent life threatening event
         subjects affected / exposed
    1 / 303 (0.33%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Croup infectious
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 303 (0.00%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    2 / 303 (0.66%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to thrive
         subjects affected / exposed
    0 / 303 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 303 (0.33%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PedHIB Group HibCY Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    280 / 303 (92.41%)
    261 / 297 (87.88%)
    Nervous system disorders
    Somnolence [Epoch 001]
         subjects affected / exposed
    248 / 303 (81.85%)
    226 / 297 (76.09%)
         occurrences all number
    524
    462
    Somnolence [Epoch 002]
         subjects affected / exposed
    117 / 303 (38.61%)
    106 / 297 (35.69%)
         occurrences all number
    117
    107
    General disorders and administration site conditions
    Pain [Epoch 001]
         subjects affected / exposed
    230 / 303 (75.91%)
    209 / 297 (70.37%)
         occurrences all number
    504
    422
    Pyrexia [Epoch 001]
         subjects affected / exposed
    145 / 303 (47.85%)
    110 / 297 (37.04%)
         occurrences all number
    216
    151
    Swelling [Epoch 001]
         subjects affected / exposed
    169 / 303 (55.78%)
    128 / 297 (43.10%)
         occurrences all number
    312
    239
    Pain [Epoch 002]
         subjects affected / exposed
    144 / 303 (47.52%)
    128 / 297 (43.10%)
         occurrences all number
    144
    128
    Pyrexia [Epoch 002]
         subjects affected / exposed
    32 / 303 (10.56%)
    38 / 297 (12.79%)
         occurrences all number
    32
    38
    Swelling [Epoch 002]
         subjects affected / exposed
    100 / 303 (33.00%)
    83 / 297 (27.95%)
         occurrences all number
    100
    83
    Gastrointestinal disorders
    Diarrhoea [Epoch 001]
         subjects affected / exposed
    14 / 303 (4.62%)
    18 / 297 (6.06%)
         occurrences all number
    15
    22
    Vomiting [Epoch 001]
         subjects affected / exposed
    15 / 303 (4.95%)
    13 / 297 (4.38%)
         occurrences all number
    16
    13
    Respiratory, thoracic and mediastinal disorders
    Cough [Epoch 001]
         subjects affected / exposed
    18 / 303 (5.94%)
    14 / 297 (4.71%)
         occurrences all number
    18
    17
    Skin and subcutaneous tissue disorders
    Erythema [Epoch 001]
         subjects affected / exposed
    198 / 303 (65.35%)
    166 / 297 (55.89%)
         occurrences all number
    407
    317
    Erythema [Epoch 002]
         subjects affected / exposed
    132 / 303 (43.56%)
    126 / 297 (42.42%)
         occurrences all number
    132
    126
    Psychiatric disorders
    Irritability [Epoch 001]
         subjects affected / exposed
    280 / 303 (92.41%)
    261 / 297 (87.88%)
         occurrences all number
    660
    577
    Irritability [Epoch 002]
         subjects affected / exposed
    179 / 303 (59.08%)
    159 / 297 (53.54%)
         occurrences all number
    179
    160
    Infections and infestations
    Otitis media [Epoch 001]
         subjects affected / exposed
    25 / 303 (8.25%)
    17 / 297 (5.72%)
         occurrences all number
    26
    20
    Upper respiratory tract infection [Epoch 001]
         subjects affected / exposed
    22 / 303 (7.26%)
    43 / 297 (14.48%)
         occurrences all number
    23
    50
    Otitis media [Epoch 002]
         subjects affected / exposed
    21 / 303 (6.93%)
    23 / 297 (7.74%)
         occurrences all number
    22
    23
    Upper respiratory tract infection [Epoch 002]
         subjects affected / exposed
    12 / 303 (3.96%)
    19 / 297 (6.40%)
         occurrences all number
    12
    20
    Metabolism and nutrition disorders
    Decreased appetite [Epoch 001]
         subjects affected / exposed
    177 / 303 (58.42%)
    157 / 297 (52.86%)
         occurrences all number
    288
    251
    Decreased appetite [Epoch 002]
         subjects affected / exposed
    96 / 303 (31.68%)
    80 / 297 (26.94%)
         occurrences all number
    96
    80

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jun 2014
    In order to provide the opportunity for subjects in the control group to receive a meningococcal vaccine, which is not routinely administered in the US to this age group, the protocol has been amended to state that: “...a parent(s)/LAR(s) of a child in the PedvaxHIB control group will be offered the opportunity for their child to be vaccinated with a licensed meningococcal vaccine, which will be provided by the study sponsor, after study end as these subjects did not have the benefit of receiving any meningococcal vaccination during the study.” Additionally, Distribution of a diary card for recording of medications/vaccinations post dose 2 of Havrix has been added. Treatment allocation is by component rather than dose. Text mentioning that subjects who do not continue in the booster phase will be contacted for safety information via a phone script at the ESFU timepoint has been added. The safety contact fax information has been updated. There have been a few changes in the contributing authors.

    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
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