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    Clinical Trial Results:
    Immunogenicity Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to Infanrix®Hexa, at 2-4-6 Months of Age in Healthy Peruvian Infants

    Summary
    EudraCT number
    		 2011-004434-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 May 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    20 Aug 2014
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A3L17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00831753
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 54 83 , emmanuel.feroldi@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 54 83 , emmanuel.feroldi@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001201-PIP01-11
    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
    27 Jul 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP-T combined vaccine induces an immune response that is at least as good as the response following Infanrix hexa™ in terms of seroprotection rates to Hep B, 1 month after a three-dose primary series (2, 4, and 6 months).
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 N/A
    Evidence for comparator
    		 Infanrix hexa™ (DTAP-HB-IPV/HB) is a licensed vaccine being studied to compare immunological and safety profiles to the investigational DTaP-IPV- Hep B-PRP~T vaccine when administered to Peruvian infants at 2, 4, and 6 months of age.
    Actual start date of recruitment
    23 May 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Peru: 263
    Worldwide total number of subjects
    263
    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)
    263
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study participants were enrolled from 23 May 2008 to 18 July 2008 at 1 clinical center in Peru.

    Pre-assignment
    Screening details
    		 A total of 263 participants who met the inclusion and and none of the exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]
    Blinding implementation details
    The investigator (blind observer or assessor) and subject’s parents or guardians did not know the vaccine administered. The assessor was in charge of the assessment of safety held in a separate room and away from where the vaccines were prepared. A nurse/vaccinator was in charge of the preparation and administration of the vaccine(s) in another room away from the assessor. When necessary the scratch off emergency decoding procedure described in the study protocol were to be followed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTaP-IPV-Hep B-PRP~T Group
    Arm description
    		 All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hexaxim
    Investigational medicinal product code
    DTaP-IPV-HepB-PRP-T vaccine
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, a dose each at age 2, 4, and 6 months, respectively.

    Arm title
    		 Infanrix Hexa™ Group
    Arm description
    		 All study participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix hexa™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, a dose each at age 2, 4, and 6 months, respectively.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The roles blinded in the study is as described.
    Number of subjects in period 1
    		DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
    Started
    132
    131
    Completed
    132
    131

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T Group
    Reporting group description
    		 All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.

    Reporting group title
    Infanrix Hexa™ Group
    Reporting group description
    		 All study participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.

    Reporting group values
    		 DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group Total
    Number of subjects
    		 132 131 263
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 132 131 263
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 1.75 ± 0.132 1.72 ± 0.123 -
    Gender categorical
    Units: Subjects
        Female
    		 58 74 132
        Male
    		 74 57 131

    End points

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    End points reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T Group
    Reporting group description
    		 All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.

    Reporting group title
    Infanrix Hexa™ Group
    Reporting group description
    		 All study participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.

    Primary: Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™

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    End point title
    		 Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ [1]
    End point description
    Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.
    End point type
    Primary
    End point timeframe
    Day 150 (1 month after 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: Descriptive analyses were performed based on the vaccine groups / vaccine administered in the study.
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
    Number of subjects analysed
    132
    130
    Units: Participants
    131
    130
    No statistical analyses for this end point

    Primary: Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine

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    End point title
    		 Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine [2]
    End point description
    Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population). Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as: Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL. Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL.
    End point type
    Primary
    End point timeframe
    Day 150 (1 month after 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: Descriptive analyses were performed based on the vaccine groups / vaccine administered in the study.
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
    Number of subjects analysed
    132
    130
    Units: Participants
        Anti-Hep B (Criteria 1)
    131
    130
        Anti-Hep B (Criteria 2)
    124
    129
        Anti-PRP (Criteria 1)
    132
    129
        Anti-PRP (Criteria 2)
    112
    109
        Anti-Diphtheria (Criteria 1)
    126
    130
        Anti-Diphtheria (Criteria 2)
    77
    85
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
    End point description
    Antibody GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population). Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.
    End point type
    Secondary
    End point timeframe
    Day 150 (1 month after dose 3)
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
    Number of subjects analysed
    132
    130
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Hep B
    986 (764 to 1270)
    1139 (961 to 1350)
        Anti-PRP
    5.22 (4.04 to 6.73)
    3.93 (3.17 to 4.86)
        Anti-Diphtheria
    0.156 (0.119 to 0.204)
    0.192 (0.154 to 0.239)
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.

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    End point title
    		 Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
    End point description
    Solicited reactions were assessed in all participants who received at least one dose of investigational or control vaccine, according to the vaccine actually received (Safety Analysis Population. Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia > 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 after each injection .
    End point values
    		 DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
    Number of subjects analysed
    132
    131
    Units: Participants
        Pain Post-injection 1
    82
    71
        Pain Post-injection 2
    68
    68
        Pain Post-injection 3
    53
    55
        Grade 3 Pain Post-any injection
    10
    6
        Erythema Post-injection 1
    32
    16
        Erythema Post-injection 2
    48
    30
        Erythema Post-injection 3
    45
    46
        Grade 3 Erythema Post-any injection
    3
    5
        Swelling Post-injection 1
    34
    12
        Swelling Post-injection 2
    26
    24
        Swelling Post-injection 3
    28
    32
        Grade 3 Swelling Post-any injection
    3
    2
        Pyrexia Post-injection 1
    11
    11
        Pyrexia Post-injection 2
    21
    17
        Pyrexia Post-injection 3
    18
    18
        Gade 3 Pyrexia Post-any injection
    0
    3
        Vomiting Post-injection 1
    20
    24
        Vomiting Post-injection 2
    8
    6
        Vomiting Post-injection 3
    6
    10
        Grade 3 Vomiting Post-any injection
    0
    0
        Crying Post-injection 1
    81
    68
        Crying Post-injection 2
    57
    52
        Crying Post-injection 3
    43
    47
        Grade 3 Crying Post-any injection
    1
    1
        Somnolence Post-injection 1
    55
    65
        Somnolence Post-injection 2
    41
    37
        Somnolence Post-injection 3
    23
    28
        Grade 3 Somnolence Post-any injection
    2
    2
        Anorexia Post-injection 1
    35
    42
        Anorexia Post-injection 2
    24
    22
        Anorexia Post-injection 3
    24
    25
        Grade 3 Anorexia Post-any injection
    0
    1
        Irritability Post-injection 1
    85
    81
        Irritability Post-injection 2
    63
    65
        Irritability Post-injection 3
    40
    55
        Grade 3 Irritability Post-any injection
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    DTaP-IPV-Hep B-PRP~T Group
    Reporting group description
    		 All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.

    Reporting group title
    Infanrix Hexa™ Group
    Reporting group description
    		 All study participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.

    Serious adverse events
    		 DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 132 (2.27%)
    2 / 131 (1.53%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Hepatobiliary disorders
    Hepatic cyst
         subjects affected / exposed
    0 / 132 (0.00%)
    1 / 131 (0.76%)
         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 obstruction
         subjects affected / exposed
    1 / 132 (0.76%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 132 (0.76%)
    0 / 131 (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
    		 DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    102 / 132 (77.27%)
    106 / 131 (80.92%)
    Nervous system disorders
    Somnolence
    alternative assessment type: Systematic
         subjects affected / exposed
    73 / 132 (55.30%)
    82 / 131 (62.60%)
         occurrences all number
    73
    82
    General disorders and administration site conditions
    Injection site haemorrhage
         subjects affected / exposed
    8 / 132 (6.06%)
    4 / 131 (3.05%)
         occurrences all number
    9
    4
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    102 / 132 (77.27%)
    101 / 131 (77.10%)
         occurrences all number
    102
    101
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    78 / 132 (59.09%)
    66 / 131 (50.38%)
         occurrences all number
    78
    66
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    54 / 132 (40.91%)
    52 / 131 (39.69%)
         occurrences all number
    54
    52
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    37 / 132 (28.03%)
    36 / 131 (27.48%)
         occurrences all number
    37
    36
    Pyrexia
         subjects affected / exposed
    11 / 132 (8.33%)
    7 / 131 (5.34%)
         occurrences all number
    13
    7
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    38 / 132 (28.79%)
    44 / 131 (33.59%)
         occurrences all number
    61
    65
    Diarrhoea
         subjects affected / exposed
    17 / 132 (12.88%)
    18 / 131 (13.74%)
         occurrences all number
    19
    21
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    29 / 132 (21.97%)
    32 / 131 (24.43%)
         occurrences all number
    29
    32
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    13 / 132 (9.85%)
    12 / 131 (9.16%)
         occurrences all number
    14
    14
    Cough
         subjects affected / exposed
    14 / 132 (10.61%)
    18 / 131 (13.74%)
         occurrences all number
    16
    24
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    9 / 132 (6.82%)
    6 / 131 (4.58%)
         occurrences all number
    9
    6
    Dermatitis diaper
         subjects affected / exposed
    14 / 132 (10.61%)
    10 / 131 (7.63%)
         occurrences all number
    15
    10
    Psychiatric disorders
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    100 / 132 (75.76%)
    98 / 131 (74.81%)
         occurrences all number
    100
    98
    Crying
    alternative assessment type: Systematic
         subjects affected / exposed
    100 / 132 (75.76%)
    93 / 131 (70.99%)
         occurrences all number
    100
    93
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    62 / 132 (46.97%)
    80 / 131 (61.07%)
         occurrences all number
    78
    118
    Pharyngitis
         subjects affected / exposed
    11 / 132 (8.33%)
    15 / 131 (11.45%)
         occurrences all number
    11
    15
    Metabolism and nutrition disorders
    Anorexia
    alternative assessment type: Systematic
         subjects affected / exposed
    54 / 132 (40.91%)
    58 / 131 (44.27%)
         occurrences all number
    54
    58

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Sep 2007
    Changes were implemented to: Clarify the term Pregnant women (or mothers within 4 weeks post partum) and their screening visits, and revision of visit intervals; Revision of inclusion/exclusion criteria; Change of the Sponsor’s Responsible Medical Officer, Clinical Scientist, and CRA; Extension of the planned trial period and the revision of the benefit/risk statement and the addition of a Secondary immunogenicity objective and endpoint concerning the detection of PRP Abs (anti Hib)
    20 Dec 2007
    Changes were implemented to: Modify the screening period of mothers; follow changes in internal standards for the Phase III studies randomization process and the use of an IVRS system; revise study duration; SAE reporting period; the revision and clarification of the per-protocol analysis set.
    25 Feb 2008
    Further clarification of the maternal screening period to define and other minor changes to IVRS text and study procedures.
    08 Dec 2008
    Change of PRP assessment method to RIA and revision of descriptions for some antigen assessment methods and a note on the change in Sponsor’s organization.

    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.
    Not applicable.
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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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